NCT07019194

An Bioequivalence Study to Compare 10mg & 20mg of Senaparib Capsules in Healthy Chinese Subjects Under Fasting Condition

An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Impact Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition

Detailed description

An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition. It was planned to enroll 40 subjects in this study.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Senaparib capsules(20mg)	Single oral dose of Senaparib administered under fasting condition, 1\*20mg capsules in first intervention period and then 2\*10mg capsules in second intervention period (after washout period: at least 5 days)
DRUG	Senaparib capsules(10mg)	Single oral dose of Senaparib administered under fasting condition, 2\*10mg capsules in first intervention period and then 1\*20mg capsules in second intervention period (after washout period: at least 5 days)

Timeline

• Start date: 2024-06-21
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: China