A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib
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|ClinicalTrials.gov Identifier: NCT04011124|
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : February 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Male Subjects||Drug: Fluzoparib Drug: Rifampicin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Fluzoparib in Healthy Male Subjects|
|Actual Study Start Date :||July 24, 2019|
|Actual Primary Completion Date :||September 16, 2019|
|Actual Study Completion Date :||September 16, 2019|
|Experimental: Rifampicin + Fluzoparib||
single dose on Day 1 and Day 12
QD on Day 5-14 for 10 days
- Peak Plasma Concentration (Cmax) of Fluzoparib [ Time Frame: Day 1 to Day 15 ]
- Area under the plasma concentration versus time curve (AUC) of Fluzoparib [ Time Frame: Day 1 to Day 15 ]
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 22 ]Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, adverse events (NCI-CTC AE 5.0), etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011124
|First Affiliated Hospital of Zhejiang University School of Medicine|
|Hangzhou, Zhejiang, China, 310003|