Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets

Summary

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

Timeline

Start

2013-10

Primary completion

2013-12

Completion

2013-12

Outcome

Met primary endpoint

registry p <0.0001; Adjusted geometric mean ratio (%) 99.98 (90% CI 97.275 to 102.751) NCT01975220 ↗

registry p <0.0001; Adjusted geometric mean ratio (%) 97.09 (90% CI 93.857 to 100.436) NCT01975220 ↗

registry p <0.0001; Adjusted geometric mean ratio (%) 100.70 (90% CI 98.28 to 103.18) NCT01975220 ↗

registry p = 0.0256; Adjusted geometric mean ratio (%) 94.65 (90% CI 82.29 to 108.88) NCT01975220 ↗

registry p <0.0001; Adjusted geometric mean ratio (%) 99.69 (90% CI 96.25 to 103.26) NCT01975220 ↗

registry p = 0.0020; Adjusted geometric mean ratio (%) 99.76 (90% CI 88.65 to 112.27) NCT01975220 ↗

registry p = 0.0072; Adjusted geometric mean ratio (%) 109.07 (90% CI 99.892 to 119.100) NCT01975220 ↗

registry p = 0.0004; Adjusted geometric mean ratio (%) 92.42 (90% CI 86.781 to 98.428) NCT01975220 ↗

registry p = 0.0014; Adjusted geometric mean ratio (%) 105.37 (90% CI 96.600 to 114.942) NCT01975220 ↗

registry p = 0.0198; Adjusted geometric mean ratio (%) 96.65 (90% CI 83.337 to 112.079) NCT01975220 ↗

registry p = 0.0007; Adjusted geometric mean ratio (%) 110.17 (90% CI 103.809 to 116.926) NCT01975220 ↗

registry p = 0.0037; Adjusted geometric mean ratio (%) 97.68 (90% CI 86.942 to 109.734) NCT01975220 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	12.5 mg	—
Subject	Empagliflozin	Small molecule	25 mg	—
Subject	Metformin	Small molecule	750 mg	—
Subject	Metformin	Small molecule	1000 mg	—

Indications

No indication recorded.