The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
This is a 2-part study with each part is an open-label study in healthy adult subjects. Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
1. It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection; 2. It is a CYP3A inhibitor combined with other drug to increase the exposure in human.
It is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
The First Hospital of Jilin University
Changchun, Jilin, China
Cmax
maximum observed plasma concentration
Time frame: predose to 96 hour after dosing
AUC
area under the plasma concentration-time curve (AUC)
Time frame: predose to 96 hour after dosing
Adverse event
To assess the safety and tolerability of therapy.
Time frame: Baseline to day 22
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