Bioequivalence of a Medium, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects. | RxWiki

Bioequivalence of a Medium, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects.

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy
Intervention	Drug: Linagliptin Drug: Metformin Drug: Linagliptin/Metformin FDC Drug: Linagliptin/Metformin FDC Drug: Linagliptin/Metformin FDC Drug: Linagliptin Drug: Metformin Drug: Metformin Drug: Linagliptin/Metformin FDC Drug: Linagliptin Drug: Metformin Drug: Linagliptin
Phase	Phase 1
Sponsor	Boehringer Ingelheim
Responsible Party	Boehringer Ingelheim
ClinicalTrials.gov Identifier	NCT02084056
First Received	March 7, 2014
Last Updated	April 2, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 7, 2014
Last Updated Date	April 2, 2014
Start Date	April 2014
Estimated Primary Completion Date	July 2014
Current Primary Outcome Measures	Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72) [Time Frame: 72 hours] [Designated as safety issue: No] Maximum measured concentration of linagliptin in plasma (Cmax) [Time Frame: 72 hours] [Designated as safety issue: No] Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [Time Frame: 72 hours] [Designated as safety issue: No] Cmax of metformin in plasma [Time Frame: 72 hours] [Designated as safety issue: No]
Current Secondary Outcome Measures	Area under the concentration-time curve of linagliptin and metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) [Time Frame: 72 hours] [Designated as safety issue: No] AUC0-inf of metformin in plasma [Time Frame: 72 hours] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Bioequivalence of a Medium, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects.
Official Title	Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (2.5 mg/1000 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	Drug: Linagliptin Linagliptin Drug: Metformin Metformin Drug: Linagliptin/Metformin FDC Linagliptin/Metformin FDC Drug: Linagliptin/Metformin FDC Linagliptin/Metformin FDC Drug: Linagliptin/Metformin FDC Linagliptin/Metformin FDC Drug: Linagliptin Linagliptin Drug: Metformin Metformin Drug: Metformin Metformin Drug: Linagliptin/Metformin FDC Linagliptin/Metformin FDC Drug: Linagliptin Linagliptin Drug: Metformin Metformin Drug: Linagliptin Linagliptin
Study Arm (s)	Experimental: FDC first, fasted Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted Experimental: Single tablets first, fasted single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted Experimental: FDC first, fed Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed Experimental: Single tablets first, fed single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	74
Estimated Completion Date	July 2014
Estimated Primary Completion Date	July 2014
Eligibility Criteria	Inclusion criteria: - Healthy male or female subjects Exclusion criteria: - Any relevant deviation from healthy condition
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT02084056
Other Study ID Numbers	1288.11
Has Data Monitoring Committee	Not Provided
Information Provided By	Boehringer Ingelheim
Study Sponsor	Boehringer Ingelheim
Collaborators	Eli Lilly and Company
Investigators	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Verification Date	April 2014

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