Bioequivalence study of bisoprolol fumarate hydrochlorothiazide tablet 10/25 mg
Not Applicable
Recruiting
- Conditions
- ---.
- Registration Number
- IRCT20230222057495N9
- Lead Sponsor
- Sami Saz Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy volunteers aged between 18 and 55 years
Body mass index less than 30 kg per square meter
All candidates must be non-smokers
Exclusion Criteria
Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg.
Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum plasma concentrations of bisoprolol fumarate and hydrochlorothiazide. Timepoint: Before taking the medicine and: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the medicine. Method of measurement: Liquid chromatography-mass spectrometry.
- Secondary Outcome Measures
Name Time Method