Empa/Lina FDC Food Effect Study (Japan)

• Status: Completed
• Trial end date: 2016-10-05
• Target enrollment: 0
• Participant gender: Male

Summary

The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Empagliflozin; Linagliptin

Criteria

Inclusion criteria:

• Healthy male subjects age >=20 and <=45 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2

• Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)

• Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Exclusion criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance

• Further exclusion criteria apply