Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01451775

2011-002836-13 (EudraCT Number)

1245.79

Details and patient eligibility

About

Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Enrollment: 18 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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18 participants in 3 patient groups

Treatment A

Experimental group

Description:

high dose of empagliflozin after overnight fasting for at least 10 h

Treatment:

Drug: Empagliflozin

Drug: Empagliflozin

Drug: Empagliflozin

Treatment B

Experimental group

Description:

high dose of empagliflozin after a standardised high fat breakfast

Treatment:

Drug: Empagliflozin

Drug: Empagliflozin

Drug: Empagliflozin

Treatment C

Experimental group

Description:

low dose empagliflozin after overnight fasting for at least 10 h

Treatment:

Drug: Empagliflozin

Drug: Empagliflozin

Drug: Empagliflozin