bioequivalence study of Eplerenone 50 mg tablet in 24 healthy male under fasting conditions
- Conditions
- Heart failure.Heart failure
- Registration Number
- IRCT20180620040164N56
- Lead Sponsor
- ACtover Pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values 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.
Subject has a history of significant renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder.
Subjects with known allergy to the products tested.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
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).