Trials / Recruiting
RecruitingNCT06376474
To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage
To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Mild, Moderate Liver Impairment and Normal Liver Function After a Single Oral Administration
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
Detailed description
To evaluate the pharmacokinetics and safety of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hemay005 | 15mg/tablet,Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 |
Timeline
- Start date
- 2024-04-28
- Primary completion
- 2025-12-10
- Completion
- 2025-12-31
- First posted
- 2024-04-19
- Last updated
- 2025-12-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06376474. Inclusion in this directory is not an endorsement.