Trials / Completed
CompletedNCT04455100
A Phase I Study of SHR1459 in Healthy Subjects
Open-Label, Single-Center, Single-arm, Fixed Sequence Study on the Effect of Itraconazole on the Pharmacokinetics of SHR1459 in Health Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Following a 10-hour overnight fast, subjects will be administered one dose of SHR1459 orally with 240 mL of ambient temperature water on Day 1. D2-D3 was the cleaning period. Itraconazole will be administered orally 200 mg/time/day form D4 to D8 after meal. On D7 following a 10-hour overnight fast, subjects will be administered SHR1459 and itraconazole 200 mg with 240 mL of ambient temperature water.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR1459/Itraconazole | SHR1459 will be administered on Day 1 and Day 7. Itraconazole will be administered on Day 4 to Day 8 |
Timeline
- Start date
- 2020-07-17
- Primary completion
- 2020-08-14
- Completion
- 2020-08-14
- First posted
- 2020-07-02
- Last updated
- 2021-10-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04455100. Inclusion in this directory is not an endorsement.