Empa/Lina FDC Food Effect Study (Japan)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2016-10-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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empagliflozin/linagliptin FDC

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

Group Type EXPERIMENTAL

empagliflozin/linagliptin FDC

Intervention Type DRUG

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

Interventions

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empagliflozin/linagliptin FDC

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

Intervention Type DRUG

Eligibility Criteria

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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