Food-Effect and Metabolism Study in Healthy Subjects

A Phase I, Open-label, 2-sequence, Cross-over, Pharmacokinetic (PK) Study to Evaluate the Effect of the Food and to Identify the Metabolism of Fluzoparib in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03062982

Enrollment

Registered

2017-02-24

Start date

2016-12-21

Completion date

2017-01-04

Last updated

2017-02-24

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

Conditions

Solid Tumor

Brief summary

This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.

Interventions

DRUGFluzoparib

2 doses separated by 7 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Able and willing to give written informed consent. * Must be willing to comply with the requirements of the study. * Willing to use a medically acceptable method (as defined by the Investigator) of birth control in the 6 months. * Male or female aged 18-50 years. * Weight more than 45kg, BMI within 18 and 28 kg/m2. * No clinically significant abnormalities in physical examination and lab tests.

Exclusion criteria

* Pregnant or breast-feeding women. * No history of alcohol or drug abuse within the past year. * Participation in any clinical trial of an experimental drug or device in the previous 3 months. * Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics - Cmax	pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h	This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Peak Plasma Concentration (Cmax) and the the 90% confidence interval were calculated.
Pharmacokinetics-AUC	pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h	This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Area under the plasma concentration versus time curve (AUC0-last，AUC0-infinity) and the 90% confidence intervals were calculated.
Pharmacokinetics - Tmax (Hours)	pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h	To estimate the the time to Maximum concentration and constructe the corresponding 90% confidence intervals.
Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC	0-96h post dose if availabel	This study was also designed to clarify the metabolism of Fluzoparib 120mg.

Countries

China

Outcome results

None listed

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