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

NCT04521192 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-08-20

No results posted yet for this study

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

DRUG

Fluzoparib

the first period: test preparation; the second period: reference preparation

DRUG

Fluzoparib

the first period: reference preparation the second period: test preparation

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2019-07-26
Completion
2019-09-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521192 on ClinicalTrials.gov