Relative Bioavailability of Two Different Vicadrostat/ Empagliflozin Combinations and Investigation of the Effect of Food on the Pharmacokinetics of a Vicadrostat/ Empagliflozin Combination in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Three- Way Crossover Study)
Abstract
To investigate the relative bioavailability of two different vicadrostat/empagliflozin combinations. Additionally, the trial investigates the effect of food on the pharmacokinetics of the vicadrostat/empagliflozin.
Conditions: Healthy.
Primary outcome: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Maximum measured concentration of the analyte in plasma (C max).
Enrollment: 32 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: 32 participants or records.
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