Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 10773; Drug: Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284621

2010-022717-25 (EudraCT Number)

1245.45

Details and patient eligibility

About

Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if ramipril affects the pharmacokinetics of BI 10773.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. healthy male and female subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 3 patient groups

BI 10773

Experimental group

Description:

1 tablet per days for 5 days, oral administration with 240 mL water for each treatment

Treatment:

Drug: BI 10773

Drug: BI 10773

Ramipril

Other group

Description:

1 tablet on day 1 and 2 tablets per day on day 2-5, oral administration with 240 mL water for each treatment

Treatment:

Drug: Ramipril

Drug: Ramipril

Drug: Ramipril

Drug: Ramipril

BI 10773 + Ramipril

Other group

Description:

1 tablet BI 10773 and 1 tablet on day 1 and 2 tablets ramipril per day on day 2-5, oral administration with 240 mL water for each treatment

Treatment:

Drug: BI 10773

Drug: Ramipril

Drug: Ramipril

Drug: BI 10773

Drug: Ramipril

Drug: Ramipril