Metoprolol succinate tablet Bioequivalence
- Conditions
- Bioequivalence study in healthy volunteers.
- Registration Number
- IRCT20130313012810N37
- Lead Sponsor
- Raha Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
The weight range of participating candidates should be between 60-100 kg.
Volunteers 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.
All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw.
History of allergic or adverse reaction to Metoprolol succinate or any similar product.
Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s).
Smokers.
Pregnant women or women who intend to become pregnant.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of the drug. Timepoint: 17 sampling time till 24h. Method of measurement: Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).
- Secondary Outcome Measures
Name Time Method