The First Hospital of Jilin University
Changchun, Jilin, 130021, China
NCT Number: NCT03662568
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
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Changchun, Jilin, 130021, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered GLS4 120 mg orally three times daily in fed state
Other names: Morphothiadine Mesilate Capsules
Administered RTV 100 mg orally three times daily in fed state
Other names: Ritonavir tablet
Administered orally ETV 0.5 mg once daily in fasted state
Other names: Entecavir table
Administered TDF 300 mg orally once daily in fasted state
Other names: Tenofovir Disoproxil Fumarate table
Time frame: Day 1-2 and Day 21-23
Maximum plasma concentration of study drugs
Time frame: Day 1-2 and Day 21-23
Area under the plasma concentration-time curve of study drugs
Time frame: Day 1-2 and Day 21-23
Time to maximum concentration of study drugs
Time frame: Day 1-2 and Day 21-23
Terminal half-life of study drugs
Time frame: Baseline to day 23
To assess the safety and tolerability after dosing
Time frame: Day 1-2 and Day 21-23
Apparent clearance of study drugs
Time frame: Day 1-2 and Day 21-23
Apparent volume of distribution of study drugs
Time frame: Day 1-2 and Day 21-23
Minimum plasma concentration of study drugs
Sunshine Lake Pharma Co., Ltd.
Industry
A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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