NCT05481385

Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The fed bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

Detailed description

To investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in Chinese healthy subjects after a single oral administration under fed conditions, and to evaluate the bioequivalence of ezetimibe tablets produced by Changzhou Pharmaceutical Factory Co., Ltd. and the licensee MSD Pharma (Singapore) PTE. Ltd. To study the safety of single oral ezetimibe tablets (specification 10mg) in Chinese healthy subjects.

Conditions

• Pharmacokinetics
• Safety

Interventions

Type	Name	Description
BEHAVIORAL	Reference preparation-Reference preparation-Test Preparation	Under fed conditions, subjects randomly divided into RRT group were given one tablet of reference preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of test preparation after cleaning period.
BEHAVIORAL	Reference preparation-Test Preparation-Reference preparation	Under fed conditions, subjects randomly divided into RTR group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period, and then one tablet of reference preparation after cleaning period.
BEHAVIORAL	Test Preparation-Reference preparation-Reference preparation	Under fed conditions, subjects randomly divided into RTR group were given one tablet of test preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of reference preparation after cleaning period.

Timeline

• Start date: 2022-07-15
• Primary completion: 2022-08-31
• Completion: 2022-12-30
• First posted: 2022-08-01
• Last updated: 2022-08-01

Locations

1 site across 1 country: China