Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Bioequivalence Study of Compound Lisinopril Tablets

Conditions
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Therapeutic Equivalency

Intervention / Treatment
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* Drug: compound lisinopril tablet
* Drug: compound lisinopril tablet(Lisonorm®)


Participation Criteria
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Eligibility Criteria
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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: 1.History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder 2.Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product 3.History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption 4.Use of any drugs or herbal medicine within 14 days prior to the first dose 5.Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compound lisinopril tablets<br>a single oral of Compound lisinopril tablets test formulation( Lisinopril 10mg/Levamlodipine besylate 5mg) | Drug: compound lisinopril tablet<br>* The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg)<br>|
| Active Comparator: Compound lisinopril tablets(Lisonorm®)<br>a single oral of Compound lisinopril tablets reference formulation( Lisinopril 10mg/Levamlodipine besylate 5mg) | Drug: compound lisinopril tablet(Lisonorm®)<br>* The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation | 90 days |