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

Healthy Adult Subjects Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04521192
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 6, 2019
Completion date September 5, 2019
View Details
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