Trials / Completed
CompletedNCT04457180
A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Repaglinide or Bupropion in Advanced Solid Tumor Subjects
A Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Apatinib Mesylate on CYP2C8 Substrate Repaglinide or CYP2B6 Substrate in Advanced Solid Tumor Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study was to assess investigate the pharmacokinetic effects of Apatinib Mesylate on CYP2C8 Substrate Repaglinide or CYP2B6 Substrate Bupropion and metabolite Hydroxy bupropion in Advanced solid tumor subjects. The secondary objective of the study was to assess the safety of Apatinib or/and Repaglinide and Bupropion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apatinib Mesylate | Apatinib will be administered daily from on D5 through D16 |
| DRUG | Repaglinide | Repaglinide will be administered daily on D1 and D12 |
| DRUG | Bupropion | Bupropion will be administered daily on D2 and D13 |
Timeline
- Start date
- 2020-11-16
- Primary completion
- 2021-05-20
- Completion
- 2021-06-19
- First posted
- 2020-07-07
- Last updated
- 2022-10-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04457180. Inclusion in this directory is not an endorsement.