NCT04692025

Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers

A Randomized, Single Center, Open-label, Phase I Study to Evaluate the Effect of Food and Fasting on the Pharmacokinetics of ASC41 Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Gannex Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.

Conditions

• Healthy
• NAFLD
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	ASC41 tablet	Oral tablet

Timeline

• Start date: 2020-12-27
• Primary completion: 2021-01-14
• Completion: 2021-01-21
• First posted: 2020-12-31
• Last updated: 2024-09-27

Locations

1 site across 1 country: China