Drug-drug Interaction Study of SPH3127
NCT05359055 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2022-07-29
Summary
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
Conditions
- Drug Drug Interaction
Interventions
- DRUG
-
SPH3127 tablet
100mg once daily on Day 1 and Day 8
- DRUG
-
Itraconazole
200mg once daily from Day 3 to Day10.
- DRUG
-
SPH3127 tablet
200mg once daily on Day 1 and Day 12.
- DRUG
-
600mg once daily from Day 3 to Day13.
Sponsors & Collaborators
-
Shanghai Pharmaceuticals Holding Co., Ltd
lead INDUSTRY
Principal Investigators
-
Qin Yu · West China Second University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-13
- Primary Completion
- 2022-01-21
- Completion
- 2022-01-21
Countries
- China
Study Locations
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