Trials / Completed
CompletedNCT04011124
A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib
A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Fluzoparib in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluzoparib | single dose on Day 1 and Day 12 |
| DRUG | Rifampicin | QD on Day 5-14 for 10 days |
Timeline
- Start date
- 2019-07-24
- Primary completion
- 2019-09-16
- Completion
- 2019-09-16
- First posted
- 2019-07-08
- Last updated
- 2020-02-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04011124. Inclusion in this directory is not an endorsement.