NCT06678542

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

A Phase 1, Open-label, Single-site, Randomized, Single-dose, Two-Period, Crossover Study to Assess the Relative Bioavailability of GP681 Powder for Oral Suspension and Tablet Formulations in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-09-27
• Primary completion: 2025-02-16
• Completion: 2025-02-16
• First posted: 2024-11-07
• Last updated: 2025-03-14

Locations

1 site across 1 country: China