Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg DR Capsules (Takeda Pharmaceuticals America Inc., USA)
Abstract
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)
Conditions: Healthy.
Primary outcome: Peak Plasma Concentration (Cmax); Area under the plasma concentration versus time curve (AUC).
Enrollment: 60 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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