NCT05316259

A Food-Effect Study of BPI-16350 in Healthy Subjects

A Phase 1, Single-center, Open-Label, Randomized, 2 Period Crossover Study to Estimate the Effect of Food on the Pharmacokinetics of BPI-16350 in Chinese Healthy Volunteers After a Single Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350. Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BPI-16350	Administered orally

Timeline

• Start date: 2022-04-15
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2022-04-07
• Last updated: 2023-05-09

Locations

1 site across 1 country: China