Trials / Completed
CompletedNCT05786339
Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects
Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- The Affiliated Hospital of Qingdao University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tested Irbesartan Tablet | T |
| DRUG | Reference Irbesartan Tablet | R |
Timeline
- Start date
- 2018-11-17
- Primary completion
- 2019-01-16
- Completion
- 2019-05-15
- First posted
- 2023-03-27
- Last updated
- 2023-03-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05786339. Inclusion in this directory is not an endorsement.