drugset / Trial / NCT06678542

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

NCT06678542

Phase 1 Completed 36 enrolled Jiangxi Qingfeng Pharmaceutical Co. Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject GP681 Unknown 20 mg Oral

Indications

No indication recorded.