Food-Effect and Metabolism Study in Healthy Subjects

Jiangsu HengRui Medicine Co., Ltd.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Solid Tumor

Interventions

FluzoparibDRUG

2 doses separated by 7 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

the First Hosital of Jilin University

Changchun, Jilin, China

Outcomes

Primary Outcomes

Pharmacokinetics - Cmax

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.

Time frame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h

Pharmacokinetics-AUC

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.

Time frame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h

Pharmacokinetics - Tmax (Hours)

To estimate the the time to Maximum concentration and constructe the corresponding 90% confidence intervals.

Time frame: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h

Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC

This study was also designed to clarify the metabolism of Fluzoparib 120mg.

Time frame: 0-96h post dose if availabel

Data from ClinicalTrials.gov

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