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What is the primary objective of this study?

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release, both under fed and fasted conditions.

Who is eligible to participate?

Inclusion criteria: - Healthy male or female subjects Exclusion criteria: - Any relevant deviation from healthy condition

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Linagliptin/Metformin ER FDC1x Linagliptin/Metformin FDC tablet

Drug:Linagliptin1x Linagliptin tablet

Drug:Metformin ER2x Metformin ER tablets

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

FDC first, fastedLinagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition

Single tablets first, fastedsingle tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition

FDC first, fedLinagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition

Single tablets first, fedsingle tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition

Study Status

Completed

Start Date: April 2014

Completed Date: July 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)

Secondary Outcome: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)

Study sponsors, principal investigator, and references

Principal Investigator: Boehringer Ingelheim

Lead Sponsor: Boehringer Ingelheim

Collaborator: Eli Lilly and Company

More information:https://clinicaltrials.gov/show/NCT02084082