Food Effect on Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers
NCT05221138 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2022-02-02
Summary
This study is a single-center, randomized, open-label, three-period crossover design, the objective is to evaluate the pharmacokinetics and safety of VV116 tablets, which are orally administered to Chinese healthy volunteers after fasting, standard diet or high-fat diet.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
VV116
VV116 oral tablets, 400mg
Sponsors & Collaborators
-
Vigonvita Life Sciences
lead INDUSTRY
Principal Investigators
-
Gangyi Liu · Shanghai Xuhui Central Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-30
- Primary Completion
- 2022-01-19
- Completion
- 2022-01-19
Countries
- China
Study Locations
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