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Bioequivalence study of Pantoprazole 40mg

Not Applicable
Conditions
Healthy volunteers.
Registration Number
IRCT20200623047902N7
Lead Sponsor
Sanamed pharma company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
24
Inclusion Criteria

General Health (liver, heart, and kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)

Exclusion Criteria

Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to pantoprazole

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Drug plasma concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12 h after drug administration. Method of measurement: HPLC -MASS-MASS.
Secondary Outcome Measures
NameTimeMethod
Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.
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