A Open-label, Single Center Drug Interaction Study Between HEC74647PA Capsule and HEC110114 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- HEC74647
- Conditions
- Chronic Hepatitis C
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects
Detailed Description
This is a 2-part study with each part is an open-label study in healthy adult subjects. Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1\~7 and Day 13\~19.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- •Be able to complete the study according to the trail protocol.
- •Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
- •Male subjects and must be 18 to 45 years of age inclusive.
- •Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive.
- •Physical examination and vital signs without clinically significant abnormalities.
Exclusion Criteria
- •Use of \>5 cigarettes per day during the past 3 months.
- •Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
- •History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
- •Donation or loss of blood over 450 mL within 3 months prior to screening.
- •12-lead ECG with clinically significant.
- •Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
- •Subjects deemed unsuitable by the investigator for any other reason.
Arms & Interventions
Part A
Subjects will receive HEC74647 on Day 1\~7 and Day13\~19, co-administration with HEC110114 on Day13\~19.
Intervention: HEC74647
Part A
Subjects will receive HEC74647 on Day 1\~7 and Day13\~19, co-administration with HEC110114 on Day13\~19.
Intervention: HEC110114
Part B
Subjects will receive HEC110114 on Day 1\~7 and Day13\~19, co-administration with HEC74647 on Day13\~19.
Intervention: HEC74647
Part B
Subjects will receive HEC110114 on Day 1\~7 and Day13\~19, co-administration with HEC74647 on Day13\~19.
Intervention: HEC110114
Outcomes
Primary Outcomes
Adverse Events
Time Frame: From Days 1-26
Incidence of adverse events
AUC
Time Frame: Day 7-12 and Day 19-26
Maximum plasma concentration of study drugs
Cmax
Time Frame: Day 7-12 and Day 19-26
Maximum plasma concentration of study drugs