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

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: BI 10773/linagliptin Drug: BI 10773/linagliptin SID Drug: BI 10773/linagliptin FDC	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Relative Bioavailability Investigations of a 25 mg BI 10773 / 5 mg Linagliptin Fixed Dose Combination (FDC) Tablet (Formulation A1) Including the Comparison With Its Mono-components, the Comparison With a Second FDC Tablet (Formulation A3), and the Investigation of Food (an Open-label, Randomised, Single Dose, Crossover, Phase I Trial in Healthy Male and Female Volunteers)

Resource links provided by NLM:

Drug Information available for: Linagliptin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

maximum measured concentration of the analyte in plasma for BI 10773 and linagliptin [ Time Frame: 4 days ] [ Designated as safety issue: No ]
area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours for linagliptin [ Time Frame: 4 days ] [ Designated as safety issue: No ]
area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration for BI 10773 [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time from last dosing to the maximum measured concentration of each analyte in plasma for BI 10773 and linagliptin [ Time Frame: 4 days ] [ Designated as safety issue: No ]
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for BI 10773 and linagliptin [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Additional pharmacokinetic parameters will be calculated as appropriate [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Vital signs (blood pressure, pulse rate) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
12-lead electrocardiogram [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Clinical laboratory tests (haematology, clinical chemistry and urinalysis) [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Assessment of tolerability by investigator [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment:	42
Study Start Date:	August 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI 10773/linagliptin FDC SID medium single dose ofBI 10773/linagliptin FDC (Formulation A1)	Drug: BI 10773/linagliptin medium single dose of BI 10773/linagliptin FDC (Formulation A1)
Experimental: BI 10773/linagliptin SID medium single dose of mono components BI 10773/linagliptin	Drug: BI 10773/linagliptin SID medium single dose of mono components BI 10773/linagliptin
Experimental: BI 10773/linagliptin FDC medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal	Drug: BI 10773/linagliptin FDC medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal
Experimental: BI 10773/linagliptin medium single dose of BI 10773/linagliptin FDC (Formulation A3)	Drug: BI 10773/linagliptin medium single dose of BI 10773/linagliptin FDC (Formulation A3)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

healthy male and female subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189201

Locations

Germany
1275.3.1 Boehringer Ingelheim Investigational Site
Biberach, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01189201 History of Changes
Other Study ID Numbers:	1275.3, 2010-019211-38
Study First Received:	August 25, 2010
Last Updated:	October 4, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

BI 1356
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013