Status:
COMPLETED
A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.
Eligibility Criteria
Inclusion
- Healthy male and female subjects over 18 years;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
- Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.
Exclusion
- Subjects with evidence of disease or major surgery;
- History of drug allergy;
- Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
- Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
- Those who have heavy smokers, alcoholics or drug abuse
- Lactating female subjects or fertile female subjects
- Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.
Key Trial Info
Start Date :
July 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05440006
Start Date
July 3 2022
End Date
July 20 2022
Last Update
September 8 2022
Active Locations (1)
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1
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China, 241000