Trials / Completed
CompletedNCT05359055
Drug-drug Interaction Study of SPH3127
An Open-label, Fixed Sequence Study to Evaluate the Effects of Multi-dose of Itraconazole or Rifampin on the Pharmacokinetic Profiles of Single Dose of SPH3127 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Rifampin | 600mg once daily from Day 3 to Day13. |
Timeline
- Start date
- 2021-12-13
- Primary completion
- 2022-01-21
- Completion
- 2022-01-21
- First posted
- 2022-05-03
- Last updated
- 2022-07-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05359055. Inclusion in this directory is not an endorsement.