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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Xiangya Hospital Central South University
Changsha, Hunan, China
Evaluation of the safety and tolerability of ASC18 in healthy volunteers: number of Adverse Events
Evaluate number of Adverse Events as a measure of safety and tolerability of ASC18.
Time frame: Up to 93 days
Cmax of ASC18
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days.
Tmax of ASC18
Evaluate the Time to reach the maximum plasma concentration after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days
AUC of ASC18
Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days
t1/2 of ASC18
Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC18 administered to Chinese healthy volunteers volunteers.
Time frame: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days
CL/F of ASC18
Evaluate the Apparent Systemic Clearance after single oral dose of ASC18 administered to Chinese healthy volunteers.
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Time frame: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days
Vd/F of ASC18
Evaluate the Apparent Volume of Distribution after single oral dose of ASC18 administered to Chinese healthy volunteers.
Time frame: On Day 1,2,3 after single doses and On Day 1,2,3,4 after multiple doses, respectively. The entire study will last up to 93 days