Empa/Lina FDC Food Effect Study (Japan)

Sponsor
Boehringer Ingelheim
Study ID
NCT02815644
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
20 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 15, 2016
Status verified
Oct 2017
Primary completion
Oct 5, 2016
Completion
Oct 5, 2016

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: empagliflozin/linagliptin FDC
    empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet

Primary Outcome Measure

Cmax for Linagliptin [ Time Frame: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration. ]

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