Full
Outline
To study the pharmacokinetic characteristics of metformin hydrochloride sustained-release tablets (0.5 g/tablet) in healthy volunteers, and to evaluate the bioequivalence of the two preparations.
A randomized, open, double-period, double-crossover trial was conducted. The tested reagent and reference reagent (Glucophage® XR®) for oral metformin hydrochloride sustained release tablets were applied to 36 healthy subjects in fasting/fed state. In this clinical trial, the validated HPLC/tandem mass spectrometry method was used to determine the concentration of metformin in human plasma of 14 time intervals in 48 h. The pharmacokinetic parameters were calculated.
After the volunteers were given tested and reference preparations in fasting/fed state, bioequivalence was evaluated by Cmax of metformin. The geometric mean ratio of Cmax was 101.12%, the 90%CI was 94.68%~108.00%, and the intra-individual variation was 16.36%. The geometric mean ratio of AUC0-t was 100.18%, the 90%CI was 95.13%~105.51%, and the intra-individual variation was 12.85%. The geometric mean ratio of AUC0-∞ was 101.06%, 90%CI was 95.86%~106.54%, and intra-individual variation was 13.11%. The geometric mean ratio of Cmax was 94.45%, the 90%CI was 90.13%~98.97%, and the intra-individual variation was 11.39%. When the AUC of metformin was used to evaluate the bioequivalence of the tested and reference preparations, the geometric mean ratio of AUC0-t was 103.21%, the 90%CI was 100.27%~106.24%, and the intra-individual variation was 7.04%. The geometric mean ratio of AUC0-∞ was 103.24%, 90%CI was 100.31%~106.26%, and intra-individual variation was 7.01%.
Both preparations were bioequivalent in fasting/postprandial status. The liquid chromatography-tandem mass spectrometry (LC-MS/MS) used in this study was accurate, rapid, sensitive and precise, providing theoretical reference for clinical safe drug use.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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