IRCT20111107008022N8
Recruiting
未知
Comparative bioequivalence study of two different Pantoprazole 40mg formulations (Exir Pharmaceutical Company & reference) in 24 Iranian volunteers
Exir Pharmaceutical Company0 sites24 target enrollmentTBD
ConditionsHealth volunteers.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health volunteers.
- Sponsor
- Exir Pharmaceutical Company
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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