1. Pharmacokinetics and Bioequivalence of Two Combination Metformin/Glipizide Tablets under Fasting and Fed Conditions in Chinese Healthy Subjects: A Randomized, Open-Label, Crossover Study.
- Author
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Lei, Yuyan, Yan, Yu, Huang, Lifeng, Li, Canxia, Liu, Wanying, Shen, Qiuxia, Wang, Caihong, Yang, Hongying, Li, Xiaohui, Zhang, Wanyu, Chen, Jing, Su, Jiankun, Xie, Yuhong, Chen, Weiming, Li, Chao, Lu, Junli, and Chen, Lulu
- Subjects
METFORMIN ,COMBINATION drug therapy ,PREPROCEDURAL fasting ,FOOD consumption ,RECEIVER operating characteristic curves ,STATISTICAL sampling ,BLOOD collection ,GLIPIZIDE ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,CROSSOVER trials ,CONFIDENCE intervals - Abstract
Metformin/glipizide tablets are a compound formulation composed of metformin hydrochloride and glipizide. This study aimed to assess the pharmacokinetics and bioequivalence of two fixed-dose combination (FDC) tablets of metformin/glipizide (500 mg/2.5 mg) in healthy Chinese subjects. We conducted a single-center, open-label, randomized, two-way crossover study with a total of 48 subjects enrolled (24 in each dietary group). The test or reference formulations were given to the subjects at random at a ratio of 1 : 1, with a seven-day washout period. Blood samples, collected at prearranged intervals before and up to 24 hours after dosage, were analyzed using validated LC-MS/MS technology to ascertain plasma concentrations of metformin and glipizide. Finally, 23 subjects completed the fasting and fed studies, respectively. In both studies, the 90% confidence intervals for the geometric mean ratios (test/reference) of the C m ax , AUC
0-t , and AUC0-∞ were all found to fall within the acceptable range for bioequivalence (80%–125%). The exposure of metformin/glipizide FDC tablets in vivo was not significantly affected by food. No serious adverse events were observed. In conclusion, this study demonstrated that both the test and reference metformin/glipizide tablets exhibited bioequivalence and were well tolerated under both fasting and fed conditions. This trial is registered with CTR202686. [ABSTRACT FROM AUTHOR]- Published
- 2024
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