NCT01111318

Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function

Pharmacokinetics, Safety and Tolerability of BI 10773 50 mg Single Dose in Male and Female Subjects With Different Degrees of Liver Impairment (Child-Pugh Classification A, B and C) as Compared to Male and Female Healthy Subjects (a Non-blinded, Parallel Group Study of Phase I)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.

Conditions

• Hepatic Insufficiency
• Healthy

Interventions

Type	Name	Description
DRUG	BI 10773	2 tablets BI 10773 25 mg single dose

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-11-01
• First posted: 2010-04-27
• Last updated: 2014-06-13
• Results posted: 2014-06-13

Locations

1 site across 1 country: Romania