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To study the pharmacokinetics of metformin hydrochloride tablets (manufactured by Beijing Zhongxin Pharmaceutical Co., Ltd.) and the reference preparation metformin hydrochloride tablets (trade name: Glycoran®, manufactured by Nippon Shinyaku Co., Ltd., Japan) in healthy subjects after single-dose administration under postprandial state, evaluate their bioequivalence, and observe the safety.
Thirty-six healthy subjects were randomly divided into two groups, 18 in each group. After having high-fat meal, the subjects took the test or reference preparations. Blood samples were collected at 0 h (after meal and before administration) and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12 and 24 h after administration. Plasma levels of metformin were measured. The trial consisted of two periods of cross administration and 7-day washout period. PhoenixTM WinNonlin® 8.1 software was used to estimate the non-compartmental pharmacokinetic parameters, and SAS9.4 software was used for statistical description and bioequivalence analysis. If the 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters (Cmax, AUC0-T, AUC0-∞) of T/R were within 80.00%~125.00% equivalent interval, it was safely proved that the two preparations were bioequivalent.
One out of 36 subjects dropped-out due to adverse events. The main pharmacokinetic parameters of the test and reference preparations were as follows: Cmax were (418.42±94.72) and (399.52±79.49) ng·mL-1, AUC0-t were (3 402.04±803.32) and (3 219.06±704.13) ng·h·mL-1; AUC0-∞ (3 458.50±815.42) and (3 276.11±715.12) ng·h·mL-1. The geometric mean ratios of Cmax, AUC0-t, AUC0-∝, and their 90% confidence intervals were 103.11% (98.69%~107.72%), 104.73 (100.11%~109.57%), and 104.63% (100.03%~109.44%), respectively. All were within the bioequivalent range of 80.00%~125.00%. No serious adverse events and unexpected adverse events occurred during the trial.
The test preparation is bioequivalent to the reference preparation after a single-dose oral administration under postprandial condition in healthy Chinese subjects. The two preparations have good safety and tolerability.
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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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