Comparative bioequivalence study of the Amiodarone 200-mg Tablets manufactured by Behestan Pharmaceutical Company
- Conditions
- bioequivalence study.
- Registration Number
- IRCT20130313012810N7
- Lead Sponsor
- Behestan Daru Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
The weight range of participating candidates must be between 60-100 kg
All candidates must be non-smokers
The candidates must be healthy in terms of physical examination, ECG and the following laboratory tests: hemoglobin, hematocrit, red and white blood count, MCV ( mean body mass), MCH (mean body hemoglobin), routine urinalysis, total cholesterol, triglycerides, total proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), amino aspartate transferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose
Volunteers who agreed to the informed consent form
History of sensitivity or idiosyncrasy to amiodarone or any of the inactive components of the formulation.
Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
Taking any medication within 2 weeks before receiving the medication.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of the drug. Timepoint: 15 sampling time till 72 h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).
- Secondary Outcome Measures
Name Time Method