Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets
NCT06610890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-12-03
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.
Conditions
Interventions
- DRUG
-
Hemay005
One 15mg tablet, four tablets at a time
- DRUG
-
Midazolam maleate
One 15mg tablet, one tablet at a time
Sponsors & Collaborators
-
Ganzhou Hemay Pharmaceutical Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-12
- Primary Completion
- 2025-01-20
- Completion
- 2025-01-20
Countries
- China
Study Locations
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