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A Study to Evaluate the the Bioequivalence of Two Different Pimicotinib Capsules in Healthy Subjects

NCT07126249 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-08-17

No results posted yet for this study

Summary

This is a study to evaluate bioequivalence and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 38 healthy subjects are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B . Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.

Conditions

  • Pharmacokinetics

Interventions

DRUG

pimicotinib capsules

pimicotinib capsules

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, Doctor · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2025-06-06
Completion
2025-06-16

Countries

  • China

Study Locations

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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 NCT07126249 on ClinicalTrials.gov