An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Condition
Abstract
To compare and evaluate the oral bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg film-coated tablets with that of Glyxambi 10 mg/ 5 mg film-coated tablets in healthy, adult, human subjects under fasting conditions.
Conditions: Type 2 Diabetes Mellitus (T2DM).
Primary outcome: Peak Plasma Concentration (Cmax); Area Under the Curve from time zero to time of last measurable concentration (AUC0-t); Peak Plasma Concentration (Cmax); Area Under the Curve from time zero to time of last measurable concentration (AUC0-72).
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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