Loading clinical trials...

A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04011124•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Sign the informed consent form before the trial and fully understand the trial content, process and possible adverse reactions;
•2. Ability to complete the study as required by the protocol;
•3. Age on the date of signing the informed consent form is 18 to 50 years old (including both ends) and is limited to male subjects only;
•4. Male subjects are willing to have no birth plans in the next 6 months and voluntarily take effective contraception;
•5. The fasting weight is not less than 50kg, and the body mass index (BMI) is in the range of 18 kg/m2 to 28 kg/m2 (including both ends);
•6. Health status: no medical history of heart, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities;
•7. Accepted physical examination results (vital signs, physical examination) and routine laboratory examination (blood routine, blood biochemistry, urine routine, etc.), 12-lead ECG, X-chest, abdominal B-ultrasound, etc. or no clinical significance if abnormal.
•8. Creatinine clearance (CLCr) ≥ 80 mL/min, and creatinine is less than or equal to the upper limit of normal

Exclusion Criteria

•1. Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, participate in blood donation within 1 month before screening and donate blood volume ≥200mL or blood loss ≥200mL, or receive blood transfusion;
•2. Allergic constitution, including a history of severe drug allergy or drug allergy; a history of allergies to fluzoparib capsule or its excipients;
•3. with drug and/or alcohol abuse history, or alcohol, nicotine and drug screening positives, or drug abuse in the past five years or used drugs 3 months before the trial; and could not prohibit smoking and alcohol during the trial period ;
•4. with medical history of cardiovascular disease such as myocarditis, coronary heart disease, pathological arrhythmia, and stroke;
•5. Pulmonary diseases, including invasive lung disease, pneumonia, dyspnea, etc.;
•6. Chronic kidney disease, renal insufficiency, history of renal anemia;
•7. have a history of dysphagia or any history of gastrointestinal disease that affects drug absorption;
•8. any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
•9. Anyone who has undergone any surgery within the first 6 months of screening; has undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, stomach reduction, etc.);
•10. with acute disease that has been clinically determined by the investigator occurred within 1 month before screening;
+9 more criteria

Locations (1)

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

July 24, 2019

Primary Completion Date

September 16, 2019

Completion Date

September 16, 2019

Last Updated

February 26, 2020

Enrollment

ACTUAL participants

Conditions

Healthy Male Subjects

Interventions

Fluzoparib

DRUG

Rifampicin

DRUG

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

NCT05245669

Healthy Male Subjects

View study

COMPLETEDPHASE1/PHASE2

A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

NCT06472531

Healthy Male SubjectsSuspected Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects

Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356

A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects

Mass Balance and Biotransformation Study of [14C]DBPR108 in Human