Trials / Completed
CompletedNCT04479891
Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects
A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pyrotinib tablet | single oral dose of SHR6390 or co-administered with itraconazole |
| DRUG | Itraconazole capsule | 200 mg itraconazole QD |
Timeline
- Start date
- 2019-09-18
- Primary completion
- 2019-10-11
- Completion
- 2019-11-30
- First posted
- 2020-07-21
- Last updated
- 2020-07-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04479891. Inclusion in this directory is not an endorsement.