Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects
- Registration Number
- NCT04232514
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A HEC110114 Subjects will receive HEC74647 on Day 1\~7 and Day13\~19, co-administration with HEC110114 on Day13\~19. Part B HEC74647 Subjects will receive HEC110114 on Day 1\~7 and Day13\~19, co-administration with HEC74647 on Day13\~19. Part A HEC74647 Subjects will receive HEC74647 on Day 1\~7 and Day13\~19, co-administration with HEC110114 on Day13\~19. Part B HEC110114 Subjects will receive HEC110114 on Day 1\~7 and Day13\~19, co-administration with HEC74647 on Day13\~19.
- Primary Outcome Measures
Name Time Method Adverse Events From Days 1-26 Incidence of adverse events
AUC Day 7-12 and Day 19-26 Maximum plasma concentration of study drugs
Cmax Day 7-12 and Day 19-26 Maximum plasma concentration of study drugs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China