NCT04358523

A Study of the Relative Bioavailability of ASC18 Tablets vs Reference Tablets in Healthy Volunteers

Drug Interaction Between RDV and SOF in ASC18 Tablets (RDV/SOF Compound Tablets) and the Influence of Food Effect on the Pharmacokinetics of ASC18 Tablets Were Evaluated in Healthy Subjects. Comparison of the Pharmacokinetic Parameters of ASC18 Tablets（Ravidasvir and Sofosbuvir Fixed Dose Combination）With Reference Tablets (Ravidasvir Sofosbuvir) in Healthy Subjects After Single and Multiple Oral Dosing

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate potential drug interaction between RDV and SOF in ASC18 tablets (RDV/SOF compound tablets) and the influence of food effect on the pharmacokinetics of ASC18 tablets were evaluated in healthy subjects -and compare the pharmacokinetic parameters of ASC18 tablets（ravidasvir and sofosbuvir fixed dose combination）with ravidasvir tablets and sofosbuvir tablets in healthy subjects after single and multiple oral dosing.

Detailed description

This randomized, open-label, crossover study will evaluate the relative bioavailability of ASC18 (ravidasvir and sofosbuvir fixed dose combination) tablets as compared to ad hoc combination of reference tablets of ravidasvir and sofosbuvir in healthy volunteers. Subjects will be randomized to 1 of 2 treatment sequences to receive multiple oral doses of either ASC18 tablets (ravidasvir and sofosbuvir fixed Dose Combination) or ravidasvir and sofosbuvir as separate tablets. In the crossover design, subjects will participate in 2 study periods with at least a 14-day washout between periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ASC18	ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg
DRUG	ravidasvir and sofosbuvir	RDV 200 mg and SOF 400 mg
DRUG	ASC18	ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg

Timeline

• Start date: 2020-03-20
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2020-04-24
• Last updated: 2021-01-11

Locations

1 site across 1 country: China