An open-label, multiple-dose study to assess the pharmacokinetics and tolerability of sitagliptin/metformin fixed-dose combination (FDC) tablet in healthy Chinese adult subjects.
| Autor: | Chen X, Zhao Q, Zhang J, Liu T, Jiang J, Hu P |
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| Jazyk: | angličtina |
| Zdroj: | International journal of clinical pharmacology and therapeutics [Int J Clin Pharmacol Ther] 2016 Sep; Vol. 54 (9), pp. 705-11. |
| DOI: | 10.5414/CP202646 |
| Abstrakt: | Aim: This study investigated the pharmacokinetics of sitagliptin and metformin after multiple oral doses of the sitagliptin/metformin fixed-dose combination (MK0431A) tablet in healthy Chinese volunteers. Methods: This was a singlecenter, randomized study in 24 healthy adults. Subjects received twice-daily doses of MK0431A 50-mg/500-mg tablet and 50-mg/850-mg tablet for 7 days. Serial blood and urine samples were collected at predefined time points for bioassay of sitagliptin and metformin. Safety was assessed throughout the study. Results: Based on consecutive trough concentrations, the steady states of sitagliptin and metformin were reached after twice-daily administration of MK0431A tablets for 5 days. After the last dose, the mean ± SD (standard deviation) peak sitagliptin concentration of 167.3 - 22.52 and 174.1 ± 22.16 ng/mL was reached in a median t Conclusion: No clinically-significant pharmacokinetic difference was identified between Chinese and foreign healthy volunteers regarding sitagliptin and metformin with multiple doses of MK0431A tablets. The treatments were well tolerated. |
| Databáze: | MEDLINE |
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