NCT05390944

An BE Study to Compare 10mg & 20mg of IMP4297 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 IMP4297 Capsules in Healthy Chinese Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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 IMP4297 capsules in healthy Chinese subjects under fasting condition.

Detailed description

An open-label, randomized, single-dose, two-way crossover bioequivalence study is designed to determine whether IMP4297 capsules 100 mg (5 × 20 mg strength) and IMP4297 capsules 100 mg (10 × 10 mg strength) are bioequivalent in healthy Chinese male subjects under fasting condition. 28 subjects (at least 22 completed) are planned to be enrolled.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IMP4297(20mg)	Single oral dose of IMP4297 administered under fasting conditions 5\*20 mg capsules in first intervention period and 10\*10 mg capsules in second intervention period (after washout period: at least 7 days)
DRUG	IMP4297(10mg)	Single oral dose of IMP4297 administered under fasting conditions 10\*10 mg capsules in first intervention period and 5\*20 mg capsules in second intervention period (after washout period: at least 7 days)

Timeline

• Start date: 2022-06-08
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2022-05-25
• Last updated: 2025-09-16

Locations

1 site across 1 country: China