NCT06610890

Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

1. To evaluate the pharmacokinetics of Hemay005 tablets on midazolam and its active metabolite α-hydroxymidazolam after multiple administration; 2. Evaluate the effect of Hemay005 tablet on QT interval; 3. To investigate the effect of Hemay 005 tablets on inflammatory factors.

Detailed description

1. To evaluate the pharmacokinetics of Hemay005 tablets on midazolam and its active metabolite α-hydroxymidazolam after multiple administration; 2. Evaluate the effect of Hemay005 tablet on QT interval; 3. To investigate the effect of Hemay 005 tablets on inflammatory factors. 4. The safety of the subjects was evaluated

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Hemay005	One 15mg tablet, four tablets at a time
DRUG	Midazolam maleate	One 15mg tablet, one tablet at a time

Timeline

• Start date: 2024-12-12
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2024-09-24
• Last updated: 2025-12-03

Locations

1 site across 1 country: China