NCT05221138

Food Effect on Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers

A Phase I Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

12 healthy subjects will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started. Investigational product administration plan given below: 12 healthy subjects will be randomized to 3 groups, i.e., Group A, Group B, Group C, with 4 subjects in each group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. Wash-out period is 3 days.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	VV116	VV116 oral tablets, 400mg

Timeline

• Start date: 2021-12-30
• Primary completion: 2022-01-19
• Completion: 2022-01-19
• First posted: 2022-02-02
• Last updated: 2022-02-02

Locations

1 site across 1 country: China