Pharmacokinetics of fixed-dose combinations of empagliflozin/metformin compared with individual tablets in healthy subjects
Autor: | Christina Rojas, Sreeraj Macha, Jasmin Link, Thomas Meinicke |
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Rok vydání: | 2016 |
Předmět: |
Adult
Male Pharmacology Bioequivalence 01 natural sciences Fixed dose EMPAGLIFLOZIN/METFORMIN 03 medical and health sciences 0302 clinical medicine Glucosides Pharmacokinetics Empagliflozin Humans Hypoglycemic Agents Medicine Pharmacology (medical) Benzhydryl Compounds Cross-Over Studies business.industry 010401 analytical chemistry Healthy subjects Middle Aged Crossover study Metformin 0104 chemical sciences Drug Combinations 030220 oncology & carcinogenesis Female business Tablets medicine.drug |
Zdroj: | Int. Journal of Clinical Pharmacology and Therapeutics. 54:282-292 |
ISSN: | 0946-1965 |
Popis: | Objective To compare the pharmacokinetics of fixed-dose combination (FDC) tablets of empagliflozin/metformin with individual tablets taken together. Methods In 3 randomized, open-label studies, healthy subjects received a single FDC tablet of empagliflozin/metformin in 1 of 6 dose combinations (empagliflozin 12.5 mg or 5 mg; metformin 500 mg, 850 mg, or 1,000 mg) in 1 period and the individual tablets taken together under fed conditions in another period. Empagliflozin 12.5 mg/metformin 1,000 mg FDC and individual tablets were also given under fasted conditions. Results Adjusted geometric mean ratios (GMRs) of empagliflozin area under the plasma concentration-time curve (AUC(0-∞)) for the FDCs vs. individual tablets ranged from 97.92 to 106.00%, and 90% CIs ranged from 93.53 to 109.39%. Adjusted GMRs of empagliflozin maximum plasma concentrations (C(max)) for the FDCs vs. individual tablets ranged from 100.97 to 106.52%, and 90% CIs ranged from 95.86 to 118.35%. Adjusted GMRs of metformin AUC(0-∞) for the FDCs vs. individual tablets ranged from 96.25 to 101.61%, and 90% CIs ranged from 88.54 to 106.62%. Adjusted GMRs of metformin C(max) for the FDCs vs. individual tablets ranged from 93.83 to 102.95%, and 90% CIs ranged from 88.01 to 109.08%. Bioequivalence was also established under fasted conditions for empagliflozin 12.5 mg/metformin 1,000 mg FDC vs. individual tablets taken together. All treatments were well tolerated. Conclusion Empagliflozin/metformin FDC tablets were found to be bioequivalent to individual tablets taken together at all tested dose strengths. |
Databáze: | OpenAIRE |
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