Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets | RxWiki

Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Overview[ - collapse ][ - ]

Purpose	To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin
Condition	Healthy
Intervention	Drug: Linagliptin/metformin Drug: Metformin Drug: Linagliptin
Phase	Phase 1
Sponsor	Boehringer Ingelheim
Responsible Party	Boehringer Ingelheim
ClinicalTrials.gov Identifier	NCT01581931
First Received	April 19, 2012
Last Updated	June 14, 2013
Last verified	June 2013

Tracking Information[ + expand ][ + ]

First Received Date	April 19, 2012
Last Updated Date	June 14, 2013
Start Date	April 2012
Estimated Primary Completion Date	June 2012
Current Primary Outcome Measures	Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin [Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours] [Designated as safety issue: No]AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean. Maximum Concentration (Cmax) of Metformin [Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours] [Designated as safety issue: No]Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.
Current Secondary Outcome Measures	Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin [Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours] [Designated as safety issue: No]AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean. Time to Maximum Concentration (Tmax) of Metformin [Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours] [Designated as safety issue: No]Time from dosing to the maximum concentration of metformin in plasma. Terminal Half-life t1/2 of Metformin [Time Frame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours] [Designated as safety issue: No]The terminal half-life of metformin in plasma is denoted by t1/2.

Descriptive Information[ + expand ][ + ]

Brief Title	Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
Official Title	Bioequivalence of Metformin Under Fed Conditions After Administration of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers, (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)
Brief Summary	To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin
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/metformin FDC Drug: Metformin single tablet Metformin Drug: Linagliptin single tablet Linagliptin
Study Arm (s)	Experimental: Linagliptin/metformin fixed dose combination tablet (FDC) Experimental: Linagliptin and metformin single tablets

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	32
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012
Eligibility Criteria	Inclusion criteria: 1. Healthy male and female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT01581931
Other Study ID Numbers	1288.20
Has Data Monitoring Committee	Not Provided
Information Provided By	Boehringer Ingelheim
Study Sponsor	Boehringer Ingelheim
Collaborators	Not Provided
Investigators	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Verification Date	June 2013

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