Bioequivalence Test of Hemay005 Tablets

NCT06610903 | Completed Phase 1

• 1 other identifier: HM005PS1S09
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）

  All subjects who receive the drug will be analyzed for pharmacokinetic

  Day1-4，Day8-11

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

  All subjects who receive the drug will be analyzed for pharmacokinetic

  Day1-4，Day8-11

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

  All subjects who receive the drug will be analyzed for pharmacokinetic

  Day1-4，Day8-11

Study Arms (2)

Healthy subject group 1

EXPERIMENTAL

15mg/tablet，one tablet each time. Participants will receive a single dose of Hemay005 tablet in Day1and Day8

Drug: Hemay005

Healthy subject group 2

EXPERIMENTAL

15mg/tablet，one tablet each time. Participants will receive a single dose of Hemay005 tablet in Day1and Day8

Drug: Hemay005

Interventions

Hemay005 DRUG

In the first cycle, 15mg (1 tablet/person) was given on an empty stomach for Hemay005-T1 or Hemay005-T2, and the second cycle was crossed over

Healthy subject group 1; Healthy subject group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female subjects aged from 18 to 65 years old (including 18 and 65 years old), with an appropriate gender ratio;
• body weight: no less than 50.0kg for men, no less than 45.0kg for women, and body mass index (BMI) \[= weight (kg)/height 2 (m2)\] between 19.0 and 26.0 kg/m2 (including boundary values);
• mmHg≤ systolic blood pressure \<140mmHg, 60mmHg≤ diastolic blood pressure \<90 mmHg, 60 BPM ≤ pulse ≤100 BPM, normal body temperature;
• have understood the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, and voluntarily participate in the clinical trial, can communicate well with the investigators, comply with the requirements of the whole study, and sign the written informed consent.

You may not qualify if:

• Participants who participated in clinical trials of other drugs/devices within 3 months and used the investigational drugs/devices;
• (Inquiry) patients with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolic system, skeletal system and other systems;
• (inquiry) the history of vomiting, diarrhea or any physiological condition that could interfere with the test results within 7 days before the test;
• (Enquire) patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic to any drug, food or pollen, or known allergic to PDE4 inhibitors (e.g., apemilast, roflumilast, etc.);
• (inquiry) those who have lost blood or donated more than 400mL of blood within 3 months before the trial, or intend to donate blood during the trial;
• (Inquiry) pregnant or lactating women, or subjects (including male subjects) who have fertility or sperm or egg donation plans from 30 days before the study to 6 months after the last dose of the study, and who are unwilling or unable to use effective contraceptive measures;
• general physical examination and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine, blood/urine pregnancy (female), etc.) within 7 days before the test, and electrocardiogram (ECG) results judged by clinicians as clinically significant within 14 days before the test;
• if one or more of hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody is clinically significant;
• (inquiry) patients who had a clinically significant major disease or underwent a major surgical operation within 3 months before the trial;
• (inquiry) Subjects who consumed more than 14 units of alcohol per week (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44mL of 40% liquor or 147 mL of 12% wine) in the 3 months before the trial, or who could not abstain from alcohol during the trial;
• (Inquired) smoked more than 5 cigarettes per day in the 3 months before the trial, or could not stop using any tobacco products during the trial;
• (inquiry) consuming excessive amounts of tea, coffee and/or caffeine-rich beverages (\> 8 cups, 1 cup =250 mL) per day in the 3 months before the study;
• (question) consumed any foods or drinks (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in caffeine/xanthine or other special ingredients (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) from screening to -2 days of admission, or could not stop eating the above foods or drinks during the study;
• (inquiry) use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids; Inhibitors (SSRI antidepressants, cimetidine, sedative- hypnotics, verapamil, fluoroquinolones, antihistamines);
• (inquiry) those who are unable to eat or have swallowing difficulties, have special dietary requirements and/or cannot follow a uniform diet;

Sponsors & Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd: lead

Study Sites (1)

Wuhan Central Hospital

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Hemay005

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: September 15, 2024
• Primary Completion: September 30, 2024
• Study Completion: February 17, 2025
• Last Updated: March 18, 2025

Record last verified: 2024-09

Locations

CN (1)