NCT07030439 - A Bioequivalence Study to Compare Senaparib Manufactured at 2 Sites in Healthy Subjects in Fasting State | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 18, 2021

Primary Completion Date

October 12, 2021

Study Completion Date

October 12, 2021

Conditions

Solid Tumor

Interventions

DRUG

Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd.

A single oral dose of 100mg of Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. (test product, manufactured at the new manufacturing site) administered in fasting state in first intervention period and then Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. (reference product, manufactured at the original manufacturing site) in second intervention period (after washout period: at least 7 days)

DRUG

Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd.

A single oral dose of 100mg of Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. (reference product, manufactured at the original manufacturing site) administered in fasting state in first intervention period and then Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. (test product, manufactured at the new manufacturing site) in second intervention period (after washout period: at least 7 days)

Trial Locations (1)

Unknown

Xuzhou Central Hospital, Xuzhou