Bioequivalence study of 300 mg ursodeoxycholic acid capsules
Not Applicable
Recruiting
- Conditions
- In the present study, no disease was investigated..
- Registration Number
- IRCT20230222057495N5
- Lead Sponsor
- Chemidarou Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy volunteers between the ages of 18 and 50
All candidates must be non-smokers
Body mass index less than 30 kg per square meter
Exclusion Criteria
Blood pressure less than 90 over 60 mm Hg or more than 140 over 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 concentration of ursodeoxycholic acid. Timepoint: 1,0.5 hours before and 0, 0.5, , 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration. Method of measurement: Liquid chromatography–mass spectrometry.
- Secondary Outcome Measures
Name Time Method