A Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects
NCT05049083 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2022-01-14
Summary
TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects.
Conditions
Interventions
- DRUG
-
New Process SHR2554 tablet、Former Process SHR2554 tablet
New Process, 350 mg SHR2554 tablets on study day 1 - Former Process, 350 mg SHR2554 tablets on study day 8
- DRUG
-
Former Process SHR2554 tablet、New Process SHR2554 tablet
Former Process, 350 mg SHR2554 tablets on study day 1 - New Process, 350 mg SHR2554 tablets on study day 8
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-17
- Primary Completion
- 2022-01-06
- Completion
- 2022-04-29
Countries
- China
Study Locations
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