Study of absorption and elimination rate of Ursodeoxycholic acid 300-mg Capsule in comparison with Ursodeoxycholic acid brand Capsule (Ursobil®).
Not Applicable
- Conditions
- Bioequivalence study.
- Registration Number
- IRCT20200407046981N41
- Lead Sponsor
- Modava pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
The weight limit of each volunteer should be between 60 and 100 kg.
All volunteers must be non-smokers.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Candidates who have consented to the consent form.
Exclusion Criteria
Known hypersensitivity or idiosyncratic reaction to Ursodeoxycholic acid or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Taking any medicine during two weeks before dosing.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: At 1 and 2 hours before dosing, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48 and 72 hours after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: At 1 and 2 hours before dosing, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48 and 72 hours after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.