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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: simvastatin; Drug: BI 10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01304329

2010-023680-18 (EudraCT Number)

1245.63

Details and patient eligibility

About

The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male and female subjects

Exclusion criteria

• Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 3 patient groups

treatment A, reference

Experimental group

Description:

1 tablet BI 10773, oral administration with 240 ml water

Treatment:

Drug: BI 10773

Drug: BI 10773

treatment B, reference

Experimental group

Description:

1 tablet simvastatin, oral administration with 240 ml water

Treatment:

Drug: simvastatin

Drug: simvastatin

treatment C, test

Experimental group

Description:

1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water

Treatment:

Drug: simvastatin

Drug: BI 10773

Drug: BI 10773

Drug: simvastatin