Trials / Completed
CompletedNCT04341090
A Food Effect Study of Apatinib Mesylate in Healthy Subjects
A Randomized, Open-label, Single Dose, Three-period, Six-sequences, Crossover Study of High-fat and Low-fat Meal Effect on the Pharmacokinetics of Apatinib Mesylate in Chinese Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (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 high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects. The secondary objective of the study was to assess the safety of apatinib mesylate administered in adult healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apatinib Mesylate | Single dose of apatinib mesylate after high-fat meal, low fat meal and fast |
Timeline
- Start date
- 2020-05-13
- Primary completion
- 2020-07-06
- Completion
- 2020-07-06
- First posted
- 2020-04-10
- Last updated
- 2021-10-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04341090. Inclusion in this directory is not an endorsement.