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

NCT05391048 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-16

No results posted yet for this study

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 fed condition

Conditions

Interventions

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)

Sponsors & Collaborators

  • Impact Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Chuanling Li · Xuzhou Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2022-07-21
Completion
2022-07-21

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391048 on ClinicalTrials.gov