drugset / Trial / NCT01451775

Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.

NCT01451775 ↗

Phase 1 Completed 18 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Timeline

Start
2011-10
Primary completion
2011-11
Completion
—

Outcome

Mixed primary results

registry Slope 0.9367 (95% CI 0.8988 to 0.9746); ANCOVA; note: Does proportionality would be assumed if the 95% confidence interval includes one. NCT01451775 ↗

registry Slope 0.9065 (95% CI 0.8011 to 1.0120); ANCOVA; note: Does proportionality would be assumed if the 95% confidence interval includes one. NCT01451775 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 10 mg —
Subject Empagliflozin Small molecule 25 mg —

Indications

No indication recorded.