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

Healthy Subjects Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy Subjects

• NCT number: NCT05221138
• Study type: Interventional
• Source: Vigonvita Life Sciences
• Status: Completed
• Phase: Phase 1
• Start date: December 30, 2021
• Completion date: January 19, 2022