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Your search keyword '"Wollbratt, Maria"' showing total 11 results
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11 results on '"Wollbratt, Maria"'

6. The glucokinase activator AZD6370 decreases fasting and postprandial glucose in type 2 diabetes mellitus patients with effects influenced by dosing regimen and food

Author

Ericsson, Hans, Sjöberg, Folke, Heijer, Maria, Dorani, Hassan, Johansson, Peter, Wollbratt, Maria, Norjavaara, Ensio, Ericsson, Hans, Sjöberg, Folke, Heijer, Maria, Dorani, Hassan, Johansson, Peter, Wollbratt, Maria, and Norjavaara, Ensio

Abstract

Aims: To investigate the pharmacodynamics, pharmacokinetics and safety of the glucokinase activator AZD6370 after 1 day of administration under fed and fasted conditions in patients with type 2 diabetes mellitus (T2DM). less thanbrgreater than less thanbrgreater thanMethods: This was a two-part study. In Part A, patients received a single oral dose of AZD6370 (20, 60 or 180 mg) or placebo in the fasted or fed states (both n = 8). In Part B, patients (n = 8) received placebo and a total dose of AZD6370 180 mg given in one, two or four divided doses. Plasma glucose, insulin and C-peptide changes versus placebo were assessed. less thanbrgreater than less thanbrgreater thanResults: AZD6370 provided dose-dependent reductions in plasma glucose of up to 30% versus placebo in both fasted and fed patients (p andlt; 0.001 at 60 and 180 mg doses). Insulin secretion increased with dose, but absolute increases were relatively small in the fasted versus fed state (0-4 h). Dosing AZD6370 twice or four-times over 1 day gave a smoother 24-h glucose profile than single-dose. AZD6370 was rapidly absorbed. Pharmacokinetics of AZD6370 were dose-independent and unaffected by food. AZD6370 was generally well tolerated. less thanbrgreater than less thanbrgreater thanConclusions: AZD6370 produced dose-dependent glucose reductions and increased glucose-stimulated insulin secretion in patients with T2DM., Funding Agencies|AstraZeneca

Published
2012
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10. Effects of ximelagatran, an oral direct thrombin inhibitor, r-hirudin and enoxaparin on thrombin generation and platelet activation in healthy male subjects

Author

Sarich, Troy C, primary, Wolzt, Michael, additional, Eriksson, Ulf G, additional, Mattsson, Christer, additional, Schmidt, Alice, additional, Elg, Susanne, additional, Andersson, Magnus, additional, Wollbratt, Maria, additional, Fager, Gunnar, additional, and Gustafsson, David, additional

Published
2003
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11. Population pharmacokinetics of melagatran, the active form of the oral direct thrombin inhibitor ximelagatran, in atrial fibrillation patients receiving long-term anticoagulation therapy.

Author

Bååthe, Sofie, Hamrén, Bengt, Karlsson, Mats O., Wollbratt, Maria, Grind, Margaretha, Eriksson, Ulf G., Bååthe, Sofie, and Hamrén, Bengt

Subjects
ANTITHROMBINS, THROMBOEMBOLISM, BLOOD coagulation, ANTICOAGULANTS, ATRIAL fibrillation, PHARMACOKINETICS, CLINICAL trials, AMINES, BIOLOGICAL models, COMPARATIVE studies, COMPUTER simulation, DRUG interactions, DRUG administration, HETEROCYCLIC compounds, RESEARCH methodology, MEDICAL cooperation, ORAL drug administration, PRODRUGS, RESEARCH, THROMBIN, EVALUATION research, CHEMICAL inhibitors, THERAPEUTICS
Abstract

Background: Ximelagatran is an oral direct thrombin inhibitor for the prevention of thromboembolic disease. After oral administration, ximelagatran is rapidly absorbed and bioconverted to its active form, melagatran.Objective: To characterise the pharmacokinetics of melagatran in patients with nonvalvular atrial fibrillation (NVAF) receiving long-term treatment for prevention of stroke and systemic embolic events.Methods: A population pharmacokinetic model was developed based on data from three phase II studies (1177 plasma concentration observations in 167 patients, treated for up to 18 months) and confirmed by including data from two phase III studies (8702 plasma concentration observations in 3188 patients, treated for up to 24 months). The impact of individualised dosing on pharmacokinetic variability was evaluated by simulations of melagatran concentrations based on the pharmacokinetic model.Results: Melagatran pharmacokinetics were consistent across the studied doses and duration of treatment, and were described by a one-compartment model with first-order absorption and elimination. Clearance of melagatran was correlated to creatinine clearance, which was the most important predictor of melagatran exposure (explained 54% of interpatient variance in clearance). Total variability (coefficient of variation) in exposure was 45%; intraindividual variability in exposure was 23%. Concomitant medication with the most common long-term used drugs in the study population had no relevant influence on melagatran pharmacokinetics. Simulations suggested that dose adjustment based on renal function or trough plasma concentration had a minor effect on overall pharmacokinetic variability and the number of patients with high melagatran exposure.Conclusion: The pharmacokinetics of melagatran in NVAF patients were predictable, and consistent with results from previously studied patient populations. Dose individualisation was predicted to have a low impact on pharmacokinetic variability, supporting the use of a fixed-dose regimen of ximelagatran for long-term anticoagulant therapy in the majority of NVAF patients. [ABSTRACT FROM AUTHOR]

Published
2006
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