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

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.

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.