Bioequivalence of Empagliflozin/Metformin (850 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study)
Abstract
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.
Conditions: Healthy.
Primary outcome: Empa: Area Under the Curve 0 to Infinity (AUC0-∞); Metformin: Area Under the Curve 0 to Infinity (AUC0-∞); Empa: Maximum Measured Concentration (Cmax); Metformin: Maximum Measured Concentration (Cmax).
Enrollment: 36 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: 36 participants or records.
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