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Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects.
- Source :
-
International journal of clinical pharmacology and therapeutics [Int J Clin Pharmacol Ther] 2015 Jul; Vol. 53 (7), pp. 582-92. - Publication Year :
- 2015
-
Abstract
- Objective: To evaluate the relative bioavailability of single pill combination (SPC) tablets of linagliptin and metformin compared with separate tablets co-administered in healthy Chinese subjects.<br />Materials and Methods: This was an open-label, single-dose, randomized, two-period, crossover study in healthy Chinese subjects with two dose groups: linagliptin 2.5 mg/metformin 850 mg and linagliptin 2.5 mg/metformin 500 mg. Within each group (n=24), subjects received one dose of the SPC tablet in one period and one dose of the separate tablets in the other. Primary endpoints were area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) and maximum plasma concentration (Cmax) for linagliptin, and AUC from 0 to the last quantifiable concentration (AUC0-tz) and Cmax for metformin.<br />Results: With the linagliptin 2.5 mg/metformin 850 mg dose, the adjusted geometric mean ratio of the SPC to the separate tablets for linagliptin was 99.53% (90% confidence interval (CI): 94.75-104.55) for AUC0-72 and 101.93% (90% CI: 95.36-108.95) for Cmax; for metformin the ratio was 96.99% (90% CI: 90.62-103.81) for AUC0-tz and 94.64% (90% CI: 85.43-104.84) for Cmax. With the linagliptin 2.5 mg/metformin 500 mg dose, the ratio with linagliptin for AUC0-72 and Cmax was 100.81% (90% CI: 95.14-106.82) and 111.37% (90% CI: 100.40-123.54), respectively; the same statistical parameters with metformin for AUC0-tz and Cmax were 102.95% (90% CI: 96.24-110.12) and 102.46% (90% CI: 92.20-113.87), respectively.<br />Conclusions: SPC tablets of linagliptin and metformin were bioequivalent to separate tablets co-administered in healthy Chinese subjects.
- Subjects :
- Administration, Oral
Adult
Area Under Curve
Asian People
Biological Availability
China
Cross-Over Studies
Dipeptidyl-Peptidase IV Inhibitors administration & dosage
Dipeptidyl-Peptidase IV Inhibitors adverse effects
Dipeptidyl-Peptidase IV Inhibitors blood
Drug Combinations
Female
Half-Life
Healthy Volunteers
Humans
Hypoglycemic Agents administration & dosage
Hypoglycemic Agents adverse effects
Hypoglycemic Agents blood
Linagliptin
Male
Metabolic Clearance Rate
Metformin administration & dosage
Metformin adverse effects
Metformin blood
Purines administration & dosage
Purines adverse effects
Purines blood
Quinazolines administration & dosage
Quinazolines adverse effects
Quinazolines blood
Tablets
Young Adult
Dipeptidyl-Peptidase IV Inhibitors pharmacokinetics
Hypoglycemic Agents pharmacokinetics
Metformin pharmacokinetics
Purines pharmacokinetics
Quinazolines pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 0946-1965
- Volume :
- 53
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- International journal of clinical pharmacology and therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 26073354
- Full Text :
- https://doi.org/10.5414/CP202237