Food-Effect and Metabolism Study in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-21

Study Completion Date

2017-01-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A

Administration of 120mg in fed state in Dosing Period 1 followed by administration of 120mg in fasted state in Dosing Period 2

Group Type EXPERIMENTAL

Fluzoparib

Intervention Type DRUG

2 doses separated by 7 days.

Group B

Administration of 120mg in fasted state in Dosing Period 1 followed by administration of 120mg in fed state in Dosing Period 2

Group Type EXPERIMENTAL

Fluzoparib

Intervention Type DRUG

2 doses separated by 7 days.

Interventions

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Fluzoparib

2 doses separated by 7 days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes