Trials / Completed
CompletedNCT04885660
Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects
Bioequivalence Study of Compound Lisinopril Tablets
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- The Affiliated Hospital of Qingdao University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The bioavailability of compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) developed by Sichuan shangrui biomedical Co., Ltd. was compared with that of reference compound lisinopril tablets (specification: lisinopril 10mg / amlodipine 5mg) produced by Hungary Gedeon Richter Pharmaceutical Co., Ltd.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 | compound lisinopril tablet | The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg) |
| DRUG | compound lisinopril tablet(Lisonorm®) | The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®) |
Timeline
- Start date
- 2018-10-12
- Primary completion
- 2018-11-15
- Completion
- 2019-11-20
- First posted
- 2021-05-13
- Last updated
- 2021-05-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04885660. Inclusion in this directory is not an endorsement.