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1. KINETICS OF DAPAGLIFLOZIN 10 MG IMMEDIATE RELEASE TABLET IN HEALTHY CAUCASIAN VOLUNTEERS: DOES FOOD INTAKE AFFECT ITS DISPOSITION IN THE BODY?

Author

OROIAN, Monica, VLASE, Ana-Maria, MARCOVICI, Adriana, and VLASE, Laurian

Subjects
FOOD consumption, DAPAGLIFLOZIN, ORAL drug administration, VOLUNTEERS, HYPOGLYCEMIC agents, INGESTION, BIOAVAILABILITY
Abstract

The aim of the current study was to investigate whether food intake alters the kinetics of dapaglliflozin, a modern anti-diabetic agent, after single-dose oral administration of a new 10 mg immediate release tablet. The evaluated formulation was developed and manufactured by Sun Pharmaceutical Industries Limited, India, and the studies were performed in healthy Caucasian subjects. The data obtained during the fasting and fed bioequivalence studies were analyzed to observe the influence of food on the bioavailability and disposition of the evaluated formulation. Although differences were observed between studies concerning some of the main parameters that describe dapagliflozin's disposition (maximum plasma concentration - Cmax, and the time to reach it -Tmax), they were proved bioequivalent. The 90% confidence intervals for the evaluated parameters were within the accepted range of 80.00-125.00% for bioequivalence conclusion, therefore the treatments are bioequivalent (dapagliflozin with/without food) and interchangeable. Hence, dapagliflozin can be administered regardless of food intake in diabetic patients. [ABSTRACT FROM AUTHOR]

Published
2023
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2. Assessing the knowledge, attitudes and practices concerning hormonal emergency contraception among female university students from Cluj-Napoca

Author

Sevastre-Berghian, Alexandra, Hanganu, Daniela, Benedec, Daniela, Oniga, Ilioara, Vlase, Laurian, Baldea, Ioana, Olteanu, Diana, Clichici, Simona, Filip, Gabriela Adriana, Ciocan, Andra, Bolboacă, Sorana D., Ciocan, Răzvan A., Nadim, Al Hajjar, Urda-Cîmpean, Andrada Elena, Pop, Cristina, Horon, Bianca, Mogoşan, Emilia, Cazacu, Irina, Cristina, Anamaria, Voştinaru, Oliviu, Anca, Emilia, Lang, Camelia, Roşioru, Corina, Erhan, Sabina, Vlad, Cristina, Capraş, Roxana-Denisa, Cordoş, Ariana-Anamaria, Blebea, Cristina, Perde-Schrepler, Maria, Bindea, Mihaela, Tatomir, Corina, Ujvary, Peter, Maniu, Alma, Tudor, Diana Valentina, Bâldea, Ioana, Lupu, Mihai, Filip, Adriana Gabriela, Schiotis, Ruxandra Elena, Radu, Catalina, Goşa, Dana, Bocşan, Corina, Buzoianu, Anca Dana, Domşa, Elena-Maria, Mureşan, Adriana, David, Luminiţa, Moldovan, Bianca, Para, Ioana, Negrean, Vasile, Andreica, Vasile, Neag, Maria Adriana, Cătinean, Adrian, Muntean, Dana Maria, Pop, Maria Raluca, Bocşan, Ioana Corina, Boţan, Emil Claudiu, Todea, M., Pop-Mureşan, M., Vulpoi, A., Popa, C., Berce, P., Simon, S., Eniu, D., Pop, Raluca M., Sabin, Octavia, Chedea, Veronica S., Boca, Andreea N., Bocşan, Corina I., Buzoianu, Anca D., Lupean, Roxana-Adelina, Crişan, Maria, Şovrea, Alina Simona, Şuşman, Sergiu Valeriu, Boşca, Adina Bianca, Melincovici, Carmen Stanca, Mărginean, Mariana Viorica, Constantin, Anne-Marie, Jianu, Mihaela Elena, Coneac, Andrei, Mocan, Lavinia Patricia, Moldovan, Ioana-Maria, Sufleţel, Rada Teodora, Mihu, Carmen Mihaela, Sitar-Taut, Adela-Viviana, Cozma, Angela, Orasan, Olga, Fodor, Adriana, Coste, Sorina, Tarmure, Simina, Pop, Dana, Zdrenghea, Dumitru, Sampelean, Dorel, Grosu, Alin, Radulescu, Dan, Grosu, Laura, Buzdugan, Elena, Crisan, Sorin, Maierean, Anca Diana, Todea, Doina Adina, Budin, Corina Eugenia, Maierean, Anca, Alexescu, Teodora, Turcanu, Anca, Semenescu, Raluca, Farcas, Loredana, Rohozneanu, Emanuela, Rădulescu, Dan, Răchişan, Andreea Liana, Dubois, Valerie, Ranchin, Bruno, Leclerc, Anne Laure Sellier, Thomas, Aurelia Bertholet, Cochat, Pierre, Bacchetta, Justine, Sava, Bianca, Mocanu, Lorena, Cismaru, Gabriel, Comsa, Horatiu, Pepine, Diana, Boarescu, Paul, Wasmuth, Alexander, Rosu, Radu, Puiu, Mihai, Gusetu, Gabriel, Condor, Ariana, Crişan, Sorin, Chiorescu, R. M., Barta, A., Mocan, M., Stoia, M. A., Anton, F. P., Mocan-Hognogi, D. L., Goidescu, C. M., Farcaş, A. D., Lazea, Cecilia, Al-Khzouz, Camelia, Bucerzan, Simona, Asavoaie, Carmen, Nascu, Ioana, Grigorescu-Sido, Paula, Sirbe, Claudia, Grigore, Madalina, Negrea, Ana-Georgeta, Suroiu, Sabrina, Borodi, Mihaela, Benta, Gabriel, Delean, Dan, Pop, Tudor L., Grama, Alina, Jianu, Cristian, Itu-Muresan, Corina, Topan, Adriana, Filipescu, Irina, Jianu, Mihaela, Bolboaca, Sorana D., Radulescu, Maria L., Neamti, Lidia, Pop, V., Stoicescu, L., Grosu, A., Radulescu, D., Cîmpianu, Mircea, Blachon, Alexandre, Chiorescu, Roxana, Stoia, Mirela, McPherson, CA, Pop, Sorin, Ruskin, Jeremy, Blendea, Dan, Florian, Teodora-Larisa, Florian, Ioan-Alexandru, Frîngu, Florina, Iosip, Adriana, Tomoaia, Raluca, Gurzau, Diana, Comşa, Horatiu, Caloian, Bogdan, Guşetu, Gabriel, Benţa, Gabriel, Căinap, Simona, Sîrbe, Claudia, Miclea, Diana, Pîrvan, Alexandru, Platon, Monica, Pop, Tudor Lucian, Ciulei, George, Orăşan, Olga Hilda, Coste, Sorina-Cezara, Procopciuc, Lucia Maria, Burac, Lucia, Aldea, Cornel, Bizo, Aurel, Bulata, Bogdan, Fufezan, Otilia, Stefanescu, Horia, Hotea, Ioana, Crisan, Tania O., Pamfil, Cristina, Badii, Medeea, Gaal, Orsolya, Peca, Loredana, Mirea, Andreea, Popp, Radu, Rednic, Simona, Joosten, Leo AB, Gheorghiu, Cristina, Simu, Gelu, Haji-Hassan, Mariam, Perné, Mirela-Georgiana, Milaciu, Mircea Vasile, Sâmpelean, Dorel, Coman, Oana-Maria, Ciumărnean, Lorena, Hăşmăşanu, Monica, Matyas, Melinda, Blaga, Ligia, Bolboacă, Sorana, Zaharie, Gabriela, (Tamaş), Adela Pătcaş, Ciule, Dorina Larisa, Vele, Paulina, Silaghi, Ciprian N., Damian, Laura O., Simon, Siao-Pin, Craciun, Alexandra M., Slavescu, Kinga Cristina, Muresan, Rodica, Mititelu, Alexandra, Tomescu, Serban, Chis, Alexandra Micu, Rednic, Mihaela, Vulturar, Romana, Lazăr, Mădălina, Sas, Valentina, Chiş, Adina, Deleanu, Călin, Man, Sorin, Schnell, Cristina, Nicolescu, Alina, Vinţan, Maria, Poliac, Teodora, Damian, Laura, Romitan, M., Radulescu, Maria, Rădulescu, D., Bădărînză, Maria, Şerban, Oana, Maghea, Lavinia, Papp, Iulia, Guţiu, Roxana-Ioana, Fodor, Daniela, Pirvan, Alexandru, Andrei, Adina, Orasan, Remus Aurel, Orasan, Olga Hilda, Bocşan, Corina Delia, Micu, Mihaela Cosmina, Albu, Adriana, Slavescu, Radu Razvan, Stoicescu, Laurenţiu, Ştefan, Georgia, Bâlteanu, Valentin Adrian, Lauzier, Benjamin, Dhot, Justine, Morgovan, Claudiu, Mogoşan, Cristina, Ghibu, Steliana, Ţaranu, Ioana, Răcătăianu, Nicoleta, Vesa, Ştefan Cristian, Pop, Raluca Maria, Matei, Daniela Maria, Paşca, Sergiu, Buzoianu, Anca-Dana, Acalovschi, Monica, Borz, Mihnea Bogdan, Schitcu, Vlad Horia, Cojocaru, Ion, Marica, Nucu Alexandru, Popescu, Dan Sorin, Munteanu, Vlad Cristian, Borz, Paul Cristian, Rădeanu, D., Dragoş, D., Girbe, S., Gondor, G., Stan, C., Maniu, A., Florian, Ioan-Stefan, Olteanu, G., Radu, M., Tui, I., Andercou, O., Stancu, B., Gherman, Claudia, Constantinescu, Ioana, Mihaileanu, F., Pintea, Daniela, Muntean, V., Simon, Ioan, Capîlnean, Teodora-Valeria, Fabian, Ovidiu, RăzvanTogănel, Mureşan, Flaviu, Deceanu, Daniel, Măluţan, Andrei Mihai, Puşcaş, Mihaela, Ciortea, Răzvan, Mocan-Hognogi, Radu Florin, Bucuri, Carmen Elena, Rada, Maria, Dudea, Marina, Mihu, Dan, Rada, Maria Patricia, Fetica, Bogdan, Clim, Adelina, Roman, Andrei, Lupan-Mureşan, Eugenia-Maria, Voicescu, George Teo, Popa, Stefania-Anda, Golea, Adela, Nechita, Vlad I., Graur, Florin, Moiş, Emil, Hajjar, Nadim A., Suciu, Viorela-Elena, Ignat, Florin Laurenţiu, Boţan, Emil-Claudiu, Bucuri, Carmen, Lăcan, Sorin-Mihai, Ungur, Ovidiu-Mihai, Stan, Constantin, Rădeanu, Doinel, Ujvary, Laszlo Peter, Blebea, Cristina Maria, Bulac, Luiza, Birta, Daiana, Chirilă, Magdalena, Ciocan, Răzvan, Crişan, Doiniţa, Constantinescu, Dan, Muntean, Valentin, Cozma-Petruţ, Anamaria, Badiu-Tişa, Ioana, Filip, Lorena, Banc, Roxana, Stanciu, Oana, Gavrilaş, Laura, Ciobârcă, Daniela, Hegheş, Codruţa, Miere, Doina, Coman, Fana-Maria, Leonte, Denisa, Brém, Balázs, Tötös, Robert, Zaharia, Valentin, Toma, Alexandra, Casoni, Dorina, Gliga, Laura-Elena, Iacob, Bogdan-Cezar, Bodoki, Ede, Oprean, Radu, Hosu, Oana, Melinte, Gheorghe, Casian, Magdolna, Săndulescu, Robert, Cristea, Cecilia, Cernat, Andreea, Irimes, Maria-Bianca, Györfi, Szabolcs János, Tertiş, Mihaela, Suciu, Maria, Anicăi, Liana, Moldovan, Radu-Cristian, Petrache, Alina, Pralea, Ioana-Ecaterina, Cogălniceanu, Gina, Mitoi, Monica, Iuga, Cristina-Adela, Paşca, Denisia, Morariu, Daniel, Buse, Mihail, Ionescu, Corina, Iuga, Cristina Adela, Pricopie, Andreea-Iulia, Ionuţ, Ioana, Marc, Gabriel, Găină, Luiza Ioana, Vodnar, Dan C., Pîrnău, Adrian, Focşan, Monica, Oniga, Ovidiu, Rus, Iulia, Gug, Ioana, Paşcalău, Violeta, Melean, Bianca, Pall, Emoke, Moldovan, Cristian, Stoian, Adrian-Ioan, Dudaş, Cosmina, Moldovan, Rebeca, Toma, Valentin, Ştiufiuc, Rareş I., Stana, Anca, Moldovan, Cadmiel, Gavan, Alexandru, Dias, Maria Inês, Pereira, Carla, Barros, Lillian, Ferreira, Isabel C.F.R., Mocan, Andrei, Crişan, Gianina, Negoi, Oana-Iuliana, Ispas, Georgiana-Ileana, Muşat, Luiza-Georgiana, Muntean, Andrei-Cătălin, Casian, Tibor, Tomuţă, Ioan, Barbălată, Cristina, Porfire, Alina, Cherfan, Anca, Iurian, Sonia, Tomuta, Ioan, Crişan, Ofelia, Hegheş, Simona-Codruţa, Ardelean, Ana-Valentina, Moisescu, Cristina, Negut, Daniel, Ardelean, Ioan, Crişan, Andrea-Gabriela, Ilyés, Kinga, Rus, Lucia, Muntean, Dana-Maria, Kiss, Bela, Loghin, Felicia, Nicoară, Raul, Ilieş, Maria, Herda, Luciana Maria, Polo, Ester, Dawson, Kenneth A., Giudice, Maria Cristina Lo, (Savencu), Ioana Petruşan, Corzo, Carolina, Salar-Behzadi, Sharareh, Fizeşan, Ionel, Pop, Anca, Iacoviţă, Cristian, Topală, Tamara, Scoruş, Lavinia, Ştiufiuc, Rareş, Lucaciu, Constantin Mihai, Rus, Lucia Maria, Kacso, Irina, Pari, Sergiu, Valica, Vladimir, Uncu, Livia, Ştefan, Maria-Georgia, Kiss, Béla, Mogoşan, Cristina Ionela, Ghibu-Morgovan, Steliana Mihaela, Dinte, Elena, Muntean, Dana, Ilea, Aranka, Miclaus, Viorel, Boşca, Bianca, Rusu, Marius Emil, Fizesan, Ionel, Gheldiu, Ana-Maria, Stefan, Maria Georgia, Mates, Letitia, Georgiu, Carmen, Vostinaru, Oliviu, Popa, Daniela-Saveta, Oroian, Monica, Pop, Diana, Marcovici, Adriana, Bhardwaj, Sandeep, Chiş, Amalia-Andreea, Chiş, Mihaela, Picos, Andrei, Badea, Mîndra, Chifor, Ioana, Rotar, Alina, Picos, Alina Monica, Ciurea, Andreea, Roman, Alexandra, Soancă, Andrada, Condor, Daniela, Micu, Iulia Cristina, Kui, Andreea, Berar, Antonela, Negucioiu, Marius, Chisnoiu, Andrea, Ispas, Ana, Buduru, Smaranda, Băbţan, Anida-Maria, Vesa, Ştefan, Boşca, Bianca Adina, Petrescu, Nausica Bianca, Feurdean, Claudia Nicoleta, Uriciuc, Willi Andrei, Ionel, Anca, Buhăţel, Dan, Sava, Arin, Andrei, Vlad, Câmpian, Radu Septimiu, Breban, Ioana Georgiana, Merfea, Mihai, Delean, Ada Gabriela, Cimpean, Sanda Ileana, Tişler, Corina Elena, Picoş, Andrei, Duncea, Ioana, Picoş, Alina Monica, Festila, Dana, Lazar, Alexandra, Selegean, Oana, Ghergie, Mircea, Ostas, Daniel, Hedesiu, Mihaela, Stan, Horatiu, Florian, Alexandru, Florian, Stefan, Bran, Simion, Dinu, Cristian, Armencea, Gabriel, Manea, Avram, Onisor, Florin, Moldovan (Lazar), Madalina Anca, Vacaras, Sergiu, Muresan, Ovidiu, Roman, Rares Calin, Baciut, Mihaela, Baciut, Grigore, Rotar, Horatiu, Crasnean, Emil, Roman, Raluca, Coclici, Alina, Cristian, Dinu, Ţermure, Dragoş Alexandru, (Dascalu), Laura Rusu, Chifor, Radu, Badea, Iulia, Simu, Meda, Badea, Mindra, Lazar, Adela Cristina, Bel, Lucia, Sarpatoczi, Orsolya, Lacatus, Radu, Taulescu, Marian, Campian, Radu Septimiu, Rusnac, Mara Elena, Gasparik, Cristina, Varvara, Bianca Elena, Dudea, Diana, Aluaş, Maria, Lucaciu, Ondine, Bordea, Roxana, Meşter, Alexandru, Colceriu-Şimon, Ioana Maria, Băciuţ, Mihaela, Ştiufiuc, Rareş Ionuţ, Aghiorghiesei, Alexandra, Ţărmure, Viorica, Hedeşiu, Mihaela, Băciuţ, Grigore, Flueraşu, Mirela, Almăşan, Oana, Iacob, Simona, Zaharia, Alina, Balhuc, Silvia, Constantiniuc, Mariana, Mirica, Ioana-Codruta, Furtos, Gabriel, Fontaine, Veronique, Moldovan, Marioara, Campian, Radu-Septimiu, Cadar, Mihai, Fluerasu, Mirela, Almasan, Oana, Sbuciumelea, Ioana, Roman, Raluca A., Ioani, Cosmin-Adrian, Părăian, Alexandra-Mirela, Suciu, Raluca, Ban, Alina, Iozon, Sofia, Şoancă, Andrada, Stoia, Sebastian, Tamaş, Tiberiu, Mitre, Ileana, Rotaru, Horaţiu, Crişan, Liana, Crişan, Bogdan, Onişor, Florin, Roman, Rareş, Mureşan, Ovidiu, Moldovan, Mădălina, Ostaş, Daniel, Almăşan, Horea, Simu, Meda-Romana, Carlot, Clémentine, Ghiran, Raluca, Lupse, Irina, Cosma, Lavinia, and Muntean, Alexandrina

Subjects
physical streiss, Medical Sciences, subclinical atherosclerosis, composite materials, fetal outcome, Pharmacy, cortisol, mechanical properties, Rhodiola Rosea, Surgical Specialties, citrus, smoking, physical training, stress, Abstracts, carotid intima- media thickness, cycle ergometer, insulin resistance, salivary pH, heart rate, oxidative stress, music, shade system, Dental Medicine, flowable resin composites, hypoxia, visceral fat thickness, Basic Sciences, modulus of elasticity, indirect aesthetic reconstruction, PubMed filters, anxiety, inflammation, cocoa, Pharmaceutical Specialties, Medicine, neuroprotection, fatigue, memantine, non-alcoholic steatohepatitis, pregnancy, Fundamental Research, hypothermia, physical effort
Published
2019

3. C1. The bioequivalence study design of highly variable drugs

Author

Marcovici, Adriana, Pop, Diana Ioana, Oroian, Monica, Bhardwaj, Sandeep, Khuroo, Arshad, Vlase, Laurian, Briciu, Corina, Ambrus, Rita, Salar-Behzadi, Sharareh, Corzo, Carolina, Lochmann, Dirk, Nagy, Zsombor K., Nagy, Brigitta, Galata, Dorián, Farkas, Attila, Marosi, György, Ancuceanu, Robert, Arsene, Andreea Letiţia, Iurian, Sonia, Tomuţă, Ioan, Gâvan, Alexandru, Casian, Tibor, Ilyés, Kinga, Gheldiu, Ana-Maria, Kochhar, Ravi, Digkas, Tryfon, Tefas, Lucia, Porfire, Alina, Bogdan, Cătălina, De Beer, Thomas, Kovács, Béla, Székely-Szentmiklósi, István, Kelemen, Éva Katalin, Szabó, Zoltán István, Sipos, Emese, Kovács-Deák, Boglárka, Székely-Szentmiklósi, Blanka, Rédai, Emőke, Szabó, Zoltán-István, Sebe, István, Zelkó, Romána, Domokos, András, Tacsi, Kornélia, Nagy, Zoltán, Costache, Teodor A., Antochi, Oana, Cucolea, Iulia, Badea, Alexandru, Covaci, Ovidiu, Obreja, Mona, Fülöp, Ibolya, Kalló, Judit-Beáta, Barna, Mátyás Botond, Fogarasi, Erzsébet, Croitoru, Mircea Dumitru, Muntean, Dana Maria, Sesarman, Alina, Abrudan, Bianca, Sylvester, Bianca, Licarete, Emilia, Rauca, Valentin, Luput, Lavinia, Patras, Laura, Banciu, Manuela, Gheldiu, Ana Maria, Şuta, Lenuţa-Maria, Ledeţi, Adriana, Ledeţi, Ionuţ, Dragomirescu, Anca, Cârcioban, Denisa, Stelea, Lavinia, Mircioiu, Constantin, Todor, Ioana, Bocşan, Corina, Buzoianu, Anca, Leucuţa, Daniel, Vicaş, Laura, Nemeth, Sebastian, Dejeu, Ioana, Jurca, Tunde, Pallag, Annamaria, Marian, Eleonora, Oprea, Oana, Popa, Marius, Barbălată, Cristina, Bulboacă, Adriana Elena, Bolboacă, Sorana D., Nicula, Cristina, Boarescu, Paul Mihai, Stănescu, Ioana, Dogaru, Gabriela, Sesărman, Alina, Dinte, Elena, Katona, Gabriel, Hales, Dana, Ledeţi, Ionuţ-Valentin, Bengescu, Cosmina, Cîrcioban, Denisa, Buda, Valentina, Suciu, Oana, Murariu, Marius, Vlase, Gabriela, Vlase, Titus, Muntean, Andrei-Cătălin, Negoi, Oana-Iuliana, Vonica, Andreea-Loredana, Rus, Luca–Liviu, Fazakas, Botond, Mircia, Eleonora, Tefas, Lucia Ruxandra, Pasca, Bianca Rita, Nutu, Andreea, Iovanov, Rareş Iuliu, Rus, Luca-Liviu, Tomoroga, Carmen, Antonoaea, Paula, Vlad, Robert, Todoran, Nicoleta, Ciurba, Adriana, Rus, Iulia, Tertiş, Mihaela, Paşcalău, Violeta, Cristea, Cecilia, Săndulescu, Robert, Suciu, Ştefana, Rus, Lucia, Porav, Alin Sebastian, Borodi, Gheorge, and Máthé, Rita

Subjects
Simvastatin, 3D-printing, crystallization, colon-specific delivery system, batch modeling, promestriene stability, pharmaceutical packaging, near infra-red, polymorphism, delayed release tablets, tenoxicam, process improvement, electrochemical analysis, diclofenac assay, injectable suspension, critical quality attributes, preformulation study, continuous pharmaceutical manufacturing, freeze-dried, cubosomes, nanosuspension, degradation, CYP2D6, dissolution prediction, coating, risk assessment, LCL, UV-Vis detection, pharmaceutical carrier, molecular mechanics, solid mixtures, Extractables and Leachables, Drylab, diabetes mellitus, rotary spinning, atomoxetine, inclusion complex, thermal analysis, fiber, root cause investigation, drug exposure, Posters, near infrared spectroscopy, lyophilization, gliclazide, doxorubicin, omeprazole, lyophilizate, pharmacokinetic drug-drug interactions, benzocaine, naproxen, particle size distribution, nanofiber, extended release, electrospinning, bioequivalence, clopidogrel, integrated technologies, dapagliflozin, orodispersible tablets, t-butanol, process analytical technology, design of experiments, DoE, drug delivery, kinetic analysis, lipid-based excipients, HPLC, centrifugal spinning, therapy personalization, EGCG, multivariate data analysis, paracetamol, pharmacokinetic drug-drug interaction, polyglycerol esters of fatty acids, Abstracts, drug delivery systems, granulation, drug approval, fluconazole, curcumin, Quality by Design, Mesalamine, wet milling, fampridine, fused deposition modelling, microfibers, clinical relevance, artificial intelligence, real-time monitoring, antioxidant properties, quality target product profile, colon cancer, critical process parameters, desogestrel, pharmacokinetics, liposomes, drug interaction mechanism, carbomer, Eudragit® FS, experimental design, particle engineering, polymer, design space, formulation, polycaprolactone, aceclofenac, complex formation, cancer, intranasal delivery, continuous manufacturing, modified release tablets, filtration, ademetionine, nonsteroidal anti-inflammatory drugs, cyclodextrins, Conferences, pulmonary administration, solid state, nanoformulation, stability, chemometrics, cyclodextrin, freeze-drying, Oral Presentations, fed, hydrogel, bioavailability, zolpidem, wet granulation
Published
2019

7. KINETICS OF GLICLAZIDE AFTER SINGLE DOSE ORAL ADMINISTRATION OF GLICLAZIDE 60 MG MODIFIED RELEASE TABLET.

Author

POP, DIANA IOANA, MARCOVICI, ADRIANA, OROIAN, MONICA, GHELDIU, ANA-MARIA, and VLASE, LAURIAN

Subjects
GLICLAZIDE, ANALYTICAL mechanics, CLINICAL pharmacology, PHARMACOKINETICS, ORDER picking systems
Abstract

The current study aimed to establish and describe the basic pharmacokinetics of a single dose of gliclazide 60 mg modified release formulation manufactured by Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries Limited, India. Ten mathematical models were created for analyzing the experimental data resulted from two bioequivalence studies conducted at Clinical Pharmacology and Pharmacokinetics Department of Terapia S.A. Model discrimination was done using the Akaike index value and it was observed that model number 10 (M10) is the model that best describes the gliclazide disposition. This model has two compartments (peripheral and central), mixed order absorption process (1st and zero order kinetics) with a lag time of around 3 hrs and 1st order kinetics of elimination. Applying this model in Phoenix software version 6.3 (Pharsight Corp., Mountain view, CA, USA) the main pharmacokinetic parameters of gliclazide were also computed. [ABSTRACT FROM AUTHOR]

Published
2020
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9. KINETICS OF DAPAGLIFLOZIN AFTER SINGLE DOSE ORAL ADMINISTRATION OF A 10 MG IMMEDIATE RELEASE TABLET.

Author

OROIAN, MONICA, MARCOVICI, ADRIANA, POP, DIANA IOANA, BHARDWAJ, SANDEEP, KHUROO, ARSHAD, GHELDIU, ANA-MARIA, and VLASE, LAURIAN

Subjects
PHARMACOKINETICS, CLINICAL pharmacology, GENERIC drugs, CLINICAL trials, DAPAGLIFLOZIN, PHARMACEUTICAL industry
Abstract

The present study aimed to elucidate and describe the basic pharmacokinetics of dapagliflozin after a single dose oral administration of a 10 mg immediate release tablet developed by Sun Pharmaceutical Industries Limited, India. Ten competing models were created in order to analyze the experimental data obtained from the 71 subjects who were enrolled and finalized two bioequivalence clinical trials, under fasting and fed state. The studies took place at the Clinical Pharmacology and Pharmacokinetics Department of Terapia S.A. Considering the Akaike index value for a rational model discrimination, model number 8 (M8) was found to be the best that fits the experimental data. The representative pharmacokinetic model involves zero order absorption kinetics with a lag time of approximately 0.3 hours, first order systemic metabolism and elimination and two-compartmental distribution. Furthermore, by using M8, the most important pharmacokinetic parameters of dapagliflozin were determined. All calculations were performed by Phoenix WinNonlin® version 6.3 (Certara, USA). [ABSTRACT FROM AUTHOR]

Published
2019
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10. IN VITRO - IN VIVO CORRELATION FOR GLICLAZIDE 60 MG MODIFIED RELEASE TABLETS.

Author

IOANA POP, DIANA, MARCOVICI, ADRIANA, OROIAN, MONICA, GHELDIU, ANA-MARIA, and VLASE, LAURIAN

Subjects
TABLETING, LABELS, GLICLAZIDE, CLINICAL trials, BLOOD sampling, DECONVOLUTION (Mathematics)
Abstract

The objective of the study was to determine in vitro -- in vivo correlations for Gliclazide 60 mg modified release tablets developed by Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries Limited, India, based on the data obtained in two bioequivalence clinical trials and in in vitro dissolution tests. Each clinical trial was designed as an open-label, randomized, single-dose, crossover study that consisted of two periods. The first bioequivalence study was performed under the fasting state of the subjects, while the second bioequivalence study was carried out under the fed state of the subjects. During each study period, venous blood samples were taken pre-dose and post-dose up to 96 hours. Afterwards, individual plasma profiles were obtained and mathematical deconvolution was applied to obtain the relative fraction absorbed of gliclazide. These data were correlated with the in vitro dissolution data obtained after performing dissolution tests in three different dissolution media, at pH 4.5, 6.8 and 7.2, with Gliclazide 60 mg modified release tablets (EvoluPharm, France). All calculation were performed by Phoenix WinNonlin® version 6.3. For each in vivo data set from the bioequivalence studies (under fasting and fed conditions), three level A in vitro-in vivo correlations were obtained for Gliclazide 60 mg modified release tablets, for in vitro tests performed at pH 4.5, 6.8, and 7.2. Good correlation coefficients were found for each established correlation (R2=0.98-0.99). In conclusion, six level A in vitro-in vivo correlations were obtained for Gliclazide 60 mg modified release tablets manufactured by Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries Limited, India. [ABSTRACT FROM AUTHOR]

Published
2019
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11. Bioequivalence of Two Formulations of Gliclazide in a Randomized Crossover Study in Healthy Caucasian Subjects Under Fasting Conditions.

Author

Pop, Diana Ioana, Oroian, Monica, Bhardwaj, Sandeep, Marcovici, Adriana, Khuroo, Arshad, Kochhar, Ravi, and Vlase, Laurian

Subjects
*THERAPEUTIC equivalency in drugs, *GLICLAZIDE, *BLOOD sampling, *DRUG administration
Abstract

This study aimed to investigate the bioequivalence of 2 formulations of gliclazide modified‐release tablets 60 mg in 48 healthy Caucasian volunteers under fasting conditions. A test product, Gliclazide MR (Ranbaxy Laboratories Limited, now Sun Pharmaceutical Industries, India), was compared with a reference product, Diamicron MR (Servier, France). The study was performed under a single‐dose, 2‐treatment, 2‐period, 2‐sequence crossover design in a fasted condition with a washout period of 21 days. Blood samples were collected for 96 hours after drug administration. Drug plasma concentrations were determined by a liquid chromatography–tandem mass spectrometry method. Analysis of pharmacokinetic characteristics was based on a noncompartmental model. The logarithmically transformed data of Cmax and AUC were analyzed for 90% confidence intervals using analysis of variance. There was no significant difference in pharmacokinetic characteristics between the products, and the 90% confidence intervals were within the acceptance range of 80.00%–125.00%. The investigated products were bioequivalent under fasted conditions. [ABSTRACT FROM AUTHOR]

Published
2019
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12. BIOEQUIVALENCE OF TWO FORMULATIONS OF GLICLAZIDE IN A RANDOMIZED CROSSOVER STUDY IN HEALTHY CAUCASIAN SUBJECTS UNDER FED CONDITION.

Author

POP, DIANA IOANA, OROIAN, MONICA, BHARDWAJ, SANDEEP, MARCOVICI, ADRIANA, KHUROO, ARSHAD, KOCHHAR, RAVI, and VLASE, LAURIAN

Subjects
THERAPEUTIC equivalency in drugs, GLICLAZIDE, DRUG tablets, LIQUID chromatography-mass spectrometry
Abstract

Copyright of Farmacia is the property of Societatea de Stiinte Farmaceutice Romania and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2018
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