NCT05841446

Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects

Single-center, Open, Randomized, Single-dose, Two-cycle, Two-sequence, Crossover Bioequivalence Study to Evaluate the Effects of the Test and the Fed States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the single-center, open, randomized, single-dose, two-cycle, two-sequence, cross-over bioequivalence of test preparation apixaban tablet 2.5mg and reference preparation 2.5mg in healthy adult subjects in fasting and fed state

Detailed description

Fasting test: 24 subjects were planned to be enrolled. Each subject was randomly assigned to one of the two groups according to a randomization table. In the first cycle, after fasting for at least 10 h, all subjects received the corresponding study drug orally in sequence starting with the first subject in the fasted state, with one group of subjects receiving the test preparation apixaban tablets 2.5 mg orally and the other group receiving the reference preparation apixaban tablets 2.5 mg orally, and then 7 days later crossed over to the second cycle of the study, which was the same as the first cycle. Postprandial trial: 30 subjects are planned to be enrolled. According to the randomization table, each subject will be randomly assigned to one of the two groups. In cycle 1, after fasting for at least 10 h, all subjects will consume one high-fat, high-heat meal starting 30 ± 0.5 min prior to study drug administration, starting with the first subject in sequence and finishing before drug administration. One group of subjects received 2.5 mg of apixaban tablets and the other group received 2.5 mg of apixaban tablets , 7 days after crossover dosing, for the second cycle of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	test apixaban tablets	specification: 2.5 mg, manufacturer: Disha Pharmaceutical Group Co., Ltd., Shandong, China
DRUG	reference apixaban tablets	specification: 2.5 mg, manufacturer: Bristol-Myers Squibb Manufacturing Company, USA

Timeline

• Start date: 2021-03-02
• Primary completion: 2021-03-17
• Completion: 2021-04-07
• First posted: 2023-05-03
• Last updated: 2023-05-03

Locations

1 site across 1 country: China