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

NCT04358523 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-11

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yahong Chen, MD · Ascletis Pharmaceuticals Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358523 on ClinicalTrials.gov