NCT06610903

Bioequivalence Test of Hemay005 Tablets

Study Protocol for a Single-center, Randomized, Open-label, Two-formulation, Single-dose, Two-cycle, Double-crossover Fasting Bioequivalence Trial of Hemay005 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.

Detailed description

To evaluate the pharmacokinetics and bioequivalence of the test formulation T1 and the control formulation T2 in healthy subjects under fasting state. The safety of the two preparations in vivo was observed

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Hemay005	In the first cycle, 15mg (1 tablet/person) was given on an empty stomach for Hemay005-T1 or Hemay005-T2, and the second cycle was crossed over

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-09-30
• Completion: 2025-02-17
• First posted: 2024-09-24
• Last updated: 2025-03-18

Locations

1 site across 1 country: China