Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers

Phase 1 Completed 96 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.

Timeline

Start: 2014-05
Primary completion: 2014-08
Completion: 2014-08

Outcome

Met primary endpoint

registry T1 (FDC) vs R1 (FC); p = 0.0000; Ratio of the geometric means 105.29 (90% CI 101.92 to 108.78) NCT02102932 ↗

registry T1 (FDC) vs R1 (FC); p = 0.0001; Ratio of the geometric means 104.56 (90% CI 97.56 to 112.07) NCT02102932 ↗

registry T1 (FDC) vs R1 (FC); p = 0.0000; Ratio of the geometric means 106.44 (90% CI 100.44 to 112.80) NCT02102932 ↗

registry T1 (FDC) vs R1 (FC); p = 0.0000; Ratio of the geometric means 104.91 (90% CI 99.29 to 110.86) NCT02102932 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	5 mg	—
Subject	Empagliflozin	Small molecule	12.5 mg	—
Subject	Metformin	Small molecule	500 mg	—
Subject	Metformin	Small molecule	850 mg	—

Indications

No indication recorded.