An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover Oral Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in Fasting Condition
Abstract
An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets 25mg/1000mg in healthy subject in fasting condition.
Conditions: Type 2 Diabetes Mellitus (T2DM).
Primary outcome: Maximum concentration obtained (Cmax); AUC from time 0 to last collection time (AUC0 - t).
Enrollment: 40 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: 40 participants or records.
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