Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-01-31

Brief Summary

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The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.

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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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Fixed dose combination

Linagliptin/Metformin

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Fixed dose combination

Metformin

Intervention Type DRUG

Combination

Free combination

Linagliptin and Metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Free combination

Linagliptin

Intervention Type DRUG

Free combination

Interventions

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Metformin

Free combination

Intervention Type DRUG

Linagliptin

Fixed dose combination

Intervention Type DRUG

Metformin

Combination

Intervention Type DRUG

Linagliptin

Free combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
* Healthy males and females according to the following criteria:

Based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests (haematology, clinical chemistry and urinalysis).

* Age 18 to 45 years (incl.)
* Body mass index by Quetelet between 18.50 to 24.99 kg/m2 (incl.)
* Female subjects of childbearing potential who agree on using double-barrier contraception during the study. If a female is postmenopausal (no menses for at least 2 years) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) she will be exempt from the requirement. In case of using oral contraceptives, these should be withdrawn at least 2 months before the first drug dosing.
* Male subjects who agree on using effective contraception during the study (barrier contraceptive methods)

Exclusion Criteria

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any laboratory value outside the reference range that is of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C)
* A positive urine drug screening test at screening and on admission to the trial site in each treatment period.
* A positive alcohol breath test at screening and on admission to the trial site in each treatment period.
* Surgery of the gastrointestinal tract (except appendectomy)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes