Bioequivalence Study of Carvedilol 12.5 mg tablet manufactured by Shafa Pharmaceutical and Coreg manufactured by GSK
Not Applicable
- Conditions
- A crossover bioequivalence study in 24 healthy volunteers.
- Registration Number
- IRCT20220209053979N10
- Lead Sponsor
- Shafa Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy male or female volunteers
Body mass index (BMI) between 18 - 30
Volunteers who are willing to sign an informed consent form
Exclusion Criteria
Familial history of heart disease
History of allergy to Carvedilol or formulation components
History or significant clinical evidence of any disease
Taking any type of medicine in the 14 days before the start of the study
Participation in any clinical study within 30 days prior to study initiation
Systolic blood pressure less than 11 and diastolic less than 7 mmHg
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 32 hours. Method of measurement: Liquid chromatography with mass spectrophotometry.
- Secondary Outcome Measures
Name Time Method Plasma concentration and then calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 32 hours. Method of measurement: Plasma concentration is measured by Liquid chromatography with mass spectrometery and pharmacokientic parameters are calculated by excel.