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Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food

NCT ID: NCT01189201

Last Updated: 2015-03-19

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects entered are planned to be included in this comparison.

The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison.

An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.

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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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BI 10773/linagliptin FDC SID

medium single dose ofBI 10773/linagliptin FDC (Formulation A1)

Group Type EXPERIMENTAL

BI 10773/linagliptin

Intervention Type DRUG

medium single dose of BI 10773/linagliptin FDC (Formulation A1)

BI 10773/linagliptin SID

medium single dose of mono components BI 10773/linagliptin

Group Type EXPERIMENTAL

BI 10773/linagliptin SID

Intervention Type DRUG

medium single dose of mono components BI 10773/linagliptin

BI 10773/linagliptin FDC

medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

Group Type EXPERIMENTAL

BI 10773/linagliptin FDC

Intervention Type DRUG

medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

BI 10773/linagliptin

medium single dose of BI 10773/linagliptin FDC (Formulation A3)

Group Type EXPERIMENTAL

BI 10773/linagliptin

Intervention Type DRUG

medium single dose of BI 10773/linagliptin FDC (Formulation A3)

Interventions

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BI 10773/linagliptin

medium single dose of BI 10773/linagliptin FDC (Formulation A1)

Intervention Type DRUG

BI 10773/linagliptin

medium single dose of BI 10773/linagliptin FDC (Formulation A3)

Intervention Type DRUG

BI 10773/linagliptin SID

medium single dose of mono components BI 10773/linagliptin

Intervention Type DRUG

BI 10773/linagliptin FDC

medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

healthy male and female subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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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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1275.3.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

References

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Glund S, Mattheus M, Runge F, Rose P, Friedrich C. Relative bioavailability of an empagliflozin 25-mg/linagliptin 5-mg fixed-dose combination tablet . Int J Clin Pharmacol Ther. 2017 Apr;55(4):355-367. doi: 10.5414/CP202929.

Reference Type DERIVED
PMID: 28290274 (View on PubMed)

Other Identifiers

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2010-019211-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1275.3

Identifier Type: -

Identifier Source: org_study_id

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