NCT04521192

Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects

A Bridging Study on the Bioequivalence of Fluzoparib Capsules With Different Specifications in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations capsules (50 mg/capsule×3). Two different specifications of fluzoparib was provided by Jiangsu HengRui Pharmaceutical Co., Ltd. The secondary objective of the study is to evaluate the safety of test preparations and reference preparation fluzoparib capsules of different specifications in healthy subjects.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	Fluzoparib	the first period: test preparation; the second period: reference preparation
DRUG	Fluzoparib	the first period: reference preparation the second period: test preparation

Timeline

• Start date: 2019-05-06
• Primary completion: 2019-07-26
• Completion: 2019-09-05
• First posted: 2020-08-20
• Last updated: 2020-08-20

Locations

1 site across 1 country: China