Relative Bioavailability Study of SHR3680
NCT04903158 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2021-05-26
Summary
This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.
Conditions
- Healthy Male Subjects
Interventions
- DRUG
-
test SHR3680 tablets
Subjects receiving a single oral dose of SHR3680 tablets with 240mg (80mg\*3)
- DRUG
-
reference SHR3680 tablets
subjects receiving a single oral dose of SHR3680 tablets with 240mg (100mg\*2+20mg\*2).
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-06
- Primary Completion
- 2021-03-15
- Completion
- 2021-05-31
Countries
- China
Study Locations
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