A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05440006

Enrollment

Registered

2022-06-30

Start date

2022-07-03

Completion date

2022-07-20

Last updated

2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

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.

Interventions

DRUGFuzuloparib

Fuzuloparib Capsules; 150mg; single dose per cycle.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

There will be 20 volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic and safety.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male and female subjects over 18 years; 2. 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); 3. Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.

Exclusion criteria

1. Subjects with evidence of disease or major surgery; 2. History of drug allergy; 3. 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; 4. 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; 5. Those who have heavy smokers, alcoholics or drug abuse 6. Lactating female subjects or fertile female subjects 7. Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.

Design outcomes

Primary

Measure	Time frame
Maximum Plasma Concentration (Cmax)	day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)	day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )	day 1 to day 10

Secondary

Measure	Time frame
The incidence and severity of adverse events/serious adverse events	from ICF signing date to approximate day 23

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026