Therapeutic Equivalency
Conditions
Brief 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.
Interventions
DRUGcompound lisinopril tablet
The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg)
DRUGcompound lisinopril tablet(Lisonorm®)
The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®)
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 90 days | Evaluate the Cmax of Lenopril and amlodipine for test preparation and reference preparation |
Countries
China
Outcome results
None listed