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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compound lisinopril tablets | Experimental | a single oral of Compound lisinopril tablets test formulation( Lisinopril 10mg/Levamlodipine besylate 5mg) |
|
| Compound lisinopril tablets(Lisonorm®) | Active Comparator | a single oral of Compound lisinopril tablets reference formulation( Lisinopril 10mg/Levamlodipine besylate 5mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compound lisinopril tablet | Drug | The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation | 90 days |
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Inclusion Criteria:
- 1.Healthy male and female aged over 18years 2.Subjects willing to provide written informed consent and to adhere to protocol requirements 3.Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.
4.Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35794660 | Derived | Li T, Liu YP, Liu SQ, Shi P, Jiang X, Tao Y, Gao XM, Ma YP, Cao Y. Bioequivalence evaluation and food effect assessment of Lisinopril/amlodipine tablets in healthy Chinese subjects under fasting and fed conditions. BMC Pharmacol Toxicol. 2022 Jul 7;23(1):45. doi: 10.1186/s40360-022-00590-6. |
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| compound lisinopril tablet(Lisonorm®) | Drug | The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®) |
|