Healthy | Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
Healthy research study
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?
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
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
Start Date: April 2014
Completed Date: July 2014
Phase: Phase 1
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