Study of Food Effects of VV913 Capsules in Chinese Healthy Volunteers
NCT07565792 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-07-14
Summary
This study is a single-center, randomized, open label, 3×3 crossover design to assess the high-fat meal and the standard meal effects on PK of a single oral dose of VV913 in healthy adult volunteers.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
VV913
A group:5 mg VV913, following an overnight fast of at least 10 hours for Period 1 ; 5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 2 ; 5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 3;
- DRUG
-
VV913
B group:5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 1 ; 5 mg VV913, following an overnight fast of at least 10 hours for Period 2 ; 5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 3;
- DRUG
-
VV913
C group:5 mg VV913, administered 30 minutes after the start of a Standard meal for Period 1;5 mg VV913, administered 30 minutes after the start of the high-fat meal for Period 2 ; 5 mg VV913, following an overnight fast of at least 10 hours for Period 3 ;
Sponsors & Collaborators
-
Vigonvita Life Sciences
lead INDUSTRY
Principal Investigators
-
Huan Zhou · The First Affiliated Hospital of Anhui Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-05-11
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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