drugset / Trial / NCT04358523

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

NCT04358523

Phase 1 Completed 50 enrolled Ascletis Pharmaceuticals Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2020-03-20
Primary completion
2020-12-15
Completion
2020-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Ravidasvir Small molecule 200 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral

Indications

No indication recorded.