Trials / Completed
CompletedNCT04328506
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- AnewPharma · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
Detailed description
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM082 tablet (test product) | Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals |
| DRUG | CM082 tablet (reference product) | Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2020-07-27
- Completion
- 2020-07-27
- First posted
- 2020-03-31
- Last updated
- 2021-11-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04328506. Inclusion in this directory is not an endorsement.