Relative Bioavailability of a 12.5 mg BI 10773 / 1000 mg Metformin Fixed Dose Combination Tablet Compared With Its Monocomponents and Administered With and Without Food (an Open-label, Randomised, Single-dose, Three-way Crossover, Phase I Trial in Healthy Volunteers)
Abstract
The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet
Conditions: Diabetes Mellitus, Type 2.
Primary outcome: Empa: Area Under the Curve 0 to Infinity (AUC0-∞); Empa: Maximum Measured Concentration (Cmax); Metformin: Area Under the Curve 0 to Infinity (AUC0-∞); Metformin: Maximum Measured Concentration (Cmax).
Enrollment: 16 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 16 participants or records.
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