Trials / Completed
CompletedNCT03536481
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of Ensartinib Capsules in Healthy Chinese Volunteers Under Fasted State and After Meal
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Betta Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
Detailed description
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of ensartinib capsules in Chinese healthy volunteers will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ensartinib capsules (test product) | Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals |
| DRUG | ensartinib capsules (reference product) | Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions |
Timeline
- Start date
- 2018-06-11
- Primary completion
- 2019-01-09
- Completion
- 2019-01-09
- First posted
- 2018-05-24
- Last updated
- 2019-07-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03536481. Inclusion in this directory is not an endorsement.