The First Hospital of Jilin University
Changchun, Jilin, 130000, China
NCT Number: NCT04551261
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Changchun, Jilin, 130000, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
Other names: ritonavir
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.
Other names: tenofovir alafenamide
Time frame: predose to 96 hour after dosing
maximum observed plasma concentration
Time frame: predose to 96 hour after dosing
area under the plasma concentration-time curve (AUC)
Time frame: Baseline to day 22
To assess the safety and tolerability of therapy.
Sunshine Lake Pharma Co., Ltd.
Industry
A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration 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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