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Study to Assess Relative Bioavailability of GP681 Formulations in Healthy Chinese Male Subjects

NCT06678542 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-14

No results posted yet for this study

Summary

The primary objective is to evaluate the relative bioavailability and pharmacokinetic profile of a single oral dose of the test formulation, GP681 Powder for Oral Suspension (20 mg/sachet), compared to the reference formulation, GP681 tablet (20 mg/tablet), in healthy Chinese male subjects. The secondary objectives are to assess the safety of a single oral dose of the GP681 Powder for Oral Suspension (20 mg/sachet) and GP681 tablet (20 mg/tablet) in healthy Chinese male subjects, as well as the palatability (taste acceptability) of the GP681 Powder for Oral Suspension.

Conditions

  • Healthy Participants

Interventions

DRUG

GP681 tablet

GP681 tablet, 20 mg, single oral dose in each Group.

DRUG

GP681 Powder for Oral Suspension

GP681 Powder for Oral Suspension, 20 mg, single oral dose in each Group.

Sponsors & Collaborators

  • Jiangxi Qingfeng Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2025-02-16
Completion
2025-02-16

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 NCT06678542 on ClinicalTrials.gov