Study of absorption and elimination rate of Pantoprazole 40 mg tablets in comparison with standard tablets of Pantoprazole (Pantonix®).
Not Applicable
Recruiting
- Conditions
- Bioequivalence study.
- Registration Number
- IRCT20200407046981N14
- Lead Sponsor
- Modava pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
The weight limit for each volunteer is between 60 and 100 kg.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Exclusion Criteria
Known hypersensitivity or idiosyncratic reaction to Pantoprazole or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10? 12? 24 and 36 hour 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 0 (before dosing), 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10? 12? 24 and 36 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.