Trials / Completed
CompletedNCT04315116
A Drug-drug Interaction Trial of Loperamide Pharmacokinetics Effect on Pyrotinib Maleate
A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Loperamide on Pyrotinib Maleate 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 primary objective of the study was to assess the effect of repeated oral doses of Loperamide on the pharmacokinetic profile of a single dose of Pyrotinib Maleate. The secondary objective of the study was to assess the safety of Pyrotinib Maleate given alone versus Fluzoparib coadministered with Loperamide.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pyrotinib maleate | a single oral dose of pyrotinib maleate on day 1 \& day10 . |
| DRUG | Loperamide | Loperamide 4 mg bid from day 7 to day 13 |
Timeline
- Start date
- 2020-04-13
- Primary completion
- 2020-04-30
- Completion
- 2020-09-01
- First posted
- 2020-03-19
- Last updated
- 2022-10-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04315116. Inclusion in this directory is not an endorsement.