Comparative randomized, single dose Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) in Healthy Human Volunteers Under Fasting Condition.
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. Minimum of 24 subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report. Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0-72 and AUC0-∞ for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0-72 and AUC0-∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Genuine Research Center GRC
Cairo, Egypt
Cmax
Maximal measured plasma concentration
Time frame: Up to12 hours post dose in each treatment period
Time of the maximum plasma concentration (Tmax)
The amount of time that a drug is present at the maximum concentration in serum
Time frame: Up to12 hours post dose in each treatment period
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