PMID- 27121669
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160429
LR  - 20220311
IS  - 2160-763X (Print)
IS  - 2160-763X (Linking)
VI  - 2
IP  - 2
DP  - 2013 Apr
TI  - Empagliflozin (BI 10773), a Potent and Selective SGLT2 Inhibitor, Induces 
      Dose-Dependent Glucosuria in Healthy Subjects.
PG  - 152-61
LID - 10.1002/cpdd.16 [doi]
AB  - Empagliflozin is an orally available, selective inhibitor of sodium glucose 
      cotransporter 2. In this study, single oral doses of empagliflozin from 0.5 to 
      800 mg were not associated with any clinically significant safety concerns in 
      healthy male volunteers. The incidence of adverse events (AEs) was similar in 
      subjects receiving placebo (22.2%) or empagliflozin (25.0%) in the single rising 
      dose part of the study and after 50 mg empagliflozin under fed (28.6%) or fasted 
      (28.6%) conditions. The most frequent AE was headache. No clinically relevant 
      changes in laboratory or electrocardiogram (ECG) measurements were observed. 
      Single oral doses of empagliflozin were rapidly absorbed, reaching peak levels 
      after 1.0-2.1 hours. Increases in empagliflozin exposure were roughly 
      dose-proportional and a dose-dependent increase in urinary glucose excretion was 
      observed for empagliflozin doses up to 100 mg. After ingestion of 50 mg 
      empagliflozin in conjunction with a high-fat, high-calorie meal, no clinically 
      relevant changes in exposure were found, indicating that empagliflozin can be 
      administered independent of food. Empagliflozin up to 800 mg did not generate 
      clinically significant safety concerns in healthy male subjects. The 
      pharmacokinetic properties of empagliflozin support once daily administration 
      independent of food.
CI  - (c) The Author(s) 2013.
FAU - Seman, Leo
AU  - Seman L
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
FAU - Macha, Sreeraj
AU  - Macha S
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
FAU - Nehmiz, Gerhard
AU  - Nehmiz G
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
FAU - Simons, Gudrun
AU  - Simons G
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
FAU - Ren, Bailuo
AU  - Ren B
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
FAU - Pinnetti, Sabine
AU  - Pinnetti S
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
FAU - Woerle, Hans J
AU  - Woerle HJ
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - Dugi, Klaus
AU  - Dugi K
AD  - Boehringer Ingelheim GmbH, Ingelheim, Germany.
LA  - eng
PT  - Journal Article
DEP - 20130327
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
OTO - NOTNLM
OT  - BI 10773
OT  - SGLT2
OT  - diabetes
OT  - empagliflozin
OT  - pharmacokinetics
EDAT- 2013/04/01 00:00
MHDA- 2013/04/01 00:01
CRDT- 2016/04/29 06:00
PHST- 2012/05/08 00:00 [received]
PHST- 2013/01/02 00:00 [accepted]
PHST- 2016/04/29 06:00 [entrez]
PHST- 2013/04/01 00:00 [pubmed]
PHST- 2013/04/01 00:01 [medline]
AID - 10.1002/cpdd.16 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2013 Apr;2(2):152-61. doi: 10.1002/cpdd.16. Epub 2013 
      Mar 27.