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A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib

NCT04011124 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-02-26

No results posted yet for this study

Summary

The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Fluzoparib.

The secondary objective of the study was to assess the safety of Fluzoparib given alone versus Fluzoparib coadministered with Rifampicin.

Conditions

  • Healthy Male Subjects

Interventions

DRUG

Fluzoparib

single dose on Day 1 and Day 12

DRUG

Rifampicin

QD on Day 5-14 for 10 days

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2019-09-16
Completion
2019-09-16

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 NCT04011124 on ClinicalTrials.gov