Comparative bioequivalence study of the Nicorandil 20-mg tablets manufactured by Modava Pharmaceoutical company
- Conditions
- -.
- Registration Number
- IRCT20130313012810N6
- Lead Sponsor
- Modava Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
The weight range of participating candidates should be between 60-100 kg
All candidates must be non-smokers
Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose
Volunteers who have agreed to an informed consent form
History of allergic or adverse reaction to nicorandil or any similar product
Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
smokers
People who have participated in other clinical studies or bioequivalence studies within 3 months before the first day of use
Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of the drug. Timepoint: 13 sampling time till 8 h. Method of measurement: LCMSMS.
- Secondary Outcome Measures
Name Time Method