A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects
NCT03662568 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2019-10-09
Summary
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
Conditions
Interventions
- DRUG
-
GLS4
Administered GLS4 120 mg orally three times daily in fed state
- DRUG
-
RTV
Administered RTV 100 mg orally three times daily in fed state
- DRUG
-
ETV
Administered orally ETV 0.5 mg once daily in fasted state
- DRUG
-
TDF
Administered TDF 300 mg orally once daily in fasted state
Sponsors & Collaborators
-
Sunshine Lake Pharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yanhua Ding, Doctor · The First Hospital of Jilin University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-06-26
- Primary Completion
- 2018-07-31
- Completion
- 2019-06-10
Countries
- China
Study Locations
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