Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 850 mg Tablets in Healthy Subjects Under Fed Conditions
Abstract
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
Conditions: Bioequivalence Study in Healthy Subjects.
Primary outcome: Bioequivalence based on the pharmacokinetic parameter: Cmax; Bioequivalence based on the pharmacokinetic parameter: AUC0-t.
Enrollment: 42 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: 42 participants or records.
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