RecruitingPhase 1

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

China24 participantsStarted 2024-04-28

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.In addition to liver function damage and complications, the investigators were in good physical condition according to medical history inquiry, vital signs, physical examination, laboratory tests (blood routine, urine routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, electroencephalogram, etc.), and no other clinically significant abnormalities.

Exclusion criteria

✕.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) \>5 times the normal value; (b) neutrophil count \<1.0×109/L; (c) hemoglobin (HGB) \<90 g/L; (d) platelet level \<50×109/L; (e) subjects with alpha-fetoprotein (AFP) \>50 ng/mL and suspected hepatocellular carcinoma;

What they're measuring

Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，half-life (T1/2)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，clearance (CL/F)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，volume of distribution (Vz/F)

Timeframe: Day1-Day6

Trial details

NCT IDNCT06376474

SponsorGanzhou Hemay Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-10

Contact for this trial

Zimeng Wang

022-24929667 wangzimeng@hemay.com.cn

View on ClinicalTrials.gov More Psoriasis trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.In addition to liver function damage and complications, the investigators were in good physical condition according to medical history inquiry, vital signs, physical examination, laboratory tests (blood routine, urine routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, electroencephalogram, etc.), and no other clinically significant abnormalities.

Exclusion criteria

✕.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) \>5 times the normal value; (b) neutrophil count \<1.0×109/L; (c) hemoglobin (HGB) \<90 g/L; (d) platelet level \<50×109/L; (e) subjects with alpha-fetoprotein (AFP) \>50 ng/mL and suspected hepatocellular carcinoma;

What they're measuring

Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，half-life (T1/2)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，clearance (CL/F)

Timeframe: Day1-Day6

Relevant pharmacokinetic parameters，volume of distribution (Vz/F)

Timeframe: Day1-Day6