Bioequivalency study of two different Pantoprazole formulations
- Conditions
- Health volunteers.
- Registration Number
- IRCT20111107008022N8
- Lead Sponsor
- Exir Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
24 healthy male and female volunteers will participate in this study
Aged 18 to 45 years based on laboratory safety tests
Paraclinical health based on tests performed
No history of diseases affecting drug pharmacokinetic processes
Lack of any chronic or acute medication at least 1 week before the start of the study
Adherence to the criteria on the basis of moral obligation and signed an informed consent
Actual weight (TBW) in the range of 20% IBW
Subject showed clinically relevant deviations from normal in physical examination.
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment
Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day.
Use any medication within 14 days before the first treatment.
A history of allergic to biguanides
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h following drug administration. Method of measurement: Using HPLC instrument.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters: Half-life, Cmax The peak plasma concentration of a drug after administration, The volume of distribution, and Clearance. Timepoint: 0; 0.5; 1.0; 2.0; 3.0; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 8.0; 9.0; 10.0 and12.0 hours post-dose. Method of measurement: Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models.