An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study of Test Product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference Product of Synjardy XR Tablets 25mg/1000mg in Healthy, Adult, Human Subjects Under Fed Condition
Abstract
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference product of Synjardy XR tablets 25mg/1000mg in Healthy, adult, human Subjects Under fed Condition.
Conditions: Type 2 Diabetes Mellitus (T2DM).
Primary outcome: For Empagliflozin & Metformin; Maximum concentration obtained (Cmax); For Empagliflozin & Metformin; 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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