Trials / Completed
CompletedNCT03652792
Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers
Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Azilsartan Tablets in Chinese Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Lee's Pharmaceutical Limited · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to determine the bioequivalence of two azilsartan formulations after administration of single doses to healthy subjects under fasted and fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azilsartan (Zhaoke) | Azilsartan 20mg tablets from Zhaoke |
| DRUG | Azilsartan (Takeda) | Azilva 20mg tablets from Takeda |
Timeline
- Start date
- 2018-01-22
- Primary completion
- 2018-06-25
- Completion
- 2018-07-05
- First posted
- 2018-08-29
- Last updated
- 2018-08-29
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT03652792. Inclusion in this directory is not an endorsement.