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To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage - Trial NCT06376474

Access comprehensive clinical trial information for NCT06376474 through Pure Global AI's free database. This Phase 1 trial is sponsored by Ganzhou Hemay Pharmaceutical Co., Ltd and is currently Not yet recruiting. The study focuses on Psoriasis. Target enrollment is 24 participants.

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NCT06376474
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.govNCT06376474
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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

Study Focus

Psoriasis

Hemay005

Interventional

drug

Sponsor & Location

Ganzhou Hemay Pharmaceutical Co., Ltd

Timeline & Enrollment

Phase 1

Apr 01, 2024

Dec 01, 2024

24 participants

Primary Outcome

Relevant pharmacokinetic parameters,Peak Plasma Concentration(Cmax),Relevant pharmacokinetic parameters,Area under the plasma concentration versus time curve(AUC0-t),Relevant pharmacokinetic parameters,Area under the curve from time 0 extrapolated to infinite time (AUC0-inf),Relevant pharmacokinetic parameters,half-life (T1/2),Relevant pharmacokinetic parameters,clearance (CL/F),Relevant pharmacokinetic parameters,volume of distribution (Vz/F)

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.

ICD-10 Classifications

Psoriasis
Other psoriasis
Psoriasis, unspecified
Arthropathic psoriasis
Psoriasis vulgaris

Data Source

ClinicalTrials.gov

NCT06376474

Non-Device Trial