Bioequivalence study of Rosuvastatin 40 mg tablet in 24 healthy male under fasting conditions
- Conditions
- Bioequivalence investigation of the generic Dorsa Pharmaceutical Co. Rosuvastatin40 mg Tablet with brand Crestor Asterazeneca Tablet..
- Registration Number
- IRCT20180620040164N22
- Lead Sponsor
- Dorsa Pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects with normal vital signs.
Subjects who agree with patient consent form.
Known hypersensitivity or idiosyncratic reaction to Rosuvastatin or inactive ingredients.
History or existence of hepatic or GI diseases or any other condition that could interfere with the absorption, distribution, excretion or metabolism of the drug.
Current or chronic history of liver disease, or know hepatic or biliary abnormalities.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
History of alcohol or drug abuse.
Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: During 2 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).