The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects
This is a 2-part study with each part is an open-label, crossover study in healthy adult subjects. Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the subject will be split into two groups and receive study drug per the defined treatment periods of Day 1, Day 11-20 and Day 21.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
The First Hospital of Jilin University
Changchun, Jilin, China
Cmax
Maximum plasma concentration of study drugs
Time frame: Day 1-2 and Day 21-23
AUC
Area under the plasma concentration-time curve of study drugs
Time frame: Day 1-2 and Day 21-23
Tmax
Time to maximum concentration of study drugs
Time frame: Day 1-2 and Day 21-23
T1/2
Terminal half-life of study drugs
Time frame: Day 1-2 and Day 21-23
Adverse events
To assess the safety and tolerability after dosing
Time frame: Baseline to day 23
CL/F
Apparent clearance of study drugs
Time frame: Day 1-2 and Day 21-23
Vz/F
Apparent volume of distribution of study drugs
Time frame: Day 1-2 and Day 21-23
Cmin
Minimum plasma concentration of study drugs
Time frame: Day 1-2 and Day 21-23
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Administered TDF 300 mg orally once daily in fasted state