Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon

Phase 1 Completed 18 enrolled Boehringer Ingelheim

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).

Timeline

Start: 2011-04
Primary completion: 2011-07
Completion: —

Outcome

Met primary endpoint

paper Geometric mean ratios (90 % CI) of AUC(τ,ss) and C (max,ss) for EE were 102.82 % (97.58, 108.35) and 99.22 % (93.40, 105.39), respectively. PMID 23512637 ↗

paper For LNG, these values were 101.94 % (98.54, 105.47) and 105.81 % (99.47, 112.55), respectively. PMID 23512637 ↗

paper The 90 % CIs were within the standard bioequivalence boundaries of 80-125 %. PMID 23512637 ↗

Publications

Macha S, Mattheus M, Pinnetti S, Woerle HJ, Broedl UC. Effect of empagliflozin on the steady-state pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female volunteers. Clin Drug Investig. 2013 May;33(5):351-7. doi: 10.1007/s40261-013-0068-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Empagliflozin	Small molecule	25 mg	Oral
Comparator	Levonorgestrel	Small molecule	150 ug	Oral
Subject	ethinyl estradiol	Small molecule	30 ug	Oral

Indications

No indication recorded.