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Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets

NCT ID: NCT02821910

Last Updated: 2020-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-20

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin \& metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.

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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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High dose, fed

1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions

Group Type EXPERIMENTAL

High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed

Intervention Type DRUG

High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

Intervention Type DRUG

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

High dose, fasted

1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions

Group Type EXPERIMENTAL

High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted

Intervention Type DRUG

High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

Intervention Type DRUG

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Low dose, fed

1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions

Group Type EXPERIMENTAL

Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed

Intervention Type DRUG

Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

Intervention Type DRUG

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Interventions

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High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed

High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

Intervention Type DRUG

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Intervention Type DRUG

High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted

High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

Intervention Type DRUG

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Intervention Type DRUG

Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed

Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

Intervention Type DRUG

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* BMI of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
* Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device Sexually abstinent A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) Surgically sterilised (including hysterectomy) Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria

* Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1361.1

Identifier Type: -

Identifier Source: org_study_id

2015-005082-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

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