Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 17 and Day 1319.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A Subjects will receive HEC74647 on Day 1~7 and Day13~19, co-administration with HEC110114 on Day13~19. |
Drug: HEC74647
Administered HEC74647 200 mg orally once daily in fed state
Drug: HEC110114
Administered HEC110114 800 mg orally once daily in fed state
|
| Experimental: Part B Subjects will receive HEC110114 on Day 1~7 and Day13~19, co-administration with HEC74647 on Day13~19. |
Drug: HEC74647
Administered HEC74647 200 mg orally once daily in fed state
Drug: HEC110114
Administered HEC110114 800 mg orally once daily in fed state
|
Outcome Measures
Primary Outcome Measures
- Adverse Events [From Days 1-26]
Incidence of adverse events
- Cmax [Day 7-12 and Day 19-26]
Maximum plasma concentration of study drugs
- AUC [Day 7-12 and Day 19-26]
Maximum plasma concentration of study drugs
Eligibility Criteria
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.
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Be able to complete the study according to the trail protocol.
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Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
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Male subjects and must be 18 to 45 years of age inclusive.
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Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive.
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Physical examination and vital signs without clinically significant abnormalities.
Exclusion Criteria:
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Use of >5 cigarettes per day during the past 3 months.
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Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
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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).
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Donation or loss of blood over 450 mL within 3 months prior to screening.
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12-lead ECG with clinically significant.
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Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
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Subjects deemed unsuitable by the investigator for any other reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of Jilin University | Changchun | Jilin | China | 130021 |
Sponsors and Collaborators
- Sunshine Lake Pharma Co., Ltd.
Investigators
- Principal Investigator: Yanhua Ding, Doctor, The First Hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HEC74647-P-03