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

• ClinicalTrials.gov Identifier: NCT01581931
• Recruitment Status: Completed
• First Posted: April 20, 2012
• Results First Posted: August 20, 2013
• Last Update Posted: August 20, 2013
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: April 19, 2012
• First Posted Date: April 20, 2012
• Results First Submitted Date: June 14, 2013
• Results First Posted Date: August 20, 2013
• Last Update Posted Date: August 20, 2013
• Study Start Date: April 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2013)

• 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 ]
  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 ]
  Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.

Original Primary Outcome Measures (submitted: April 19, 2012)

• Number of participants with AUC0-tz (area under the plasma concentration-time curve over the time interval from 0 to the time tz of the last measurable concentration ) [ Time Frame: up to 72 hours ]
• Number of participants with Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]

• Change History: Complete list of historical versions of study NCT01581931 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 14, 2013)

• 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 ]
  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 ]
  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 ]
  The terminal half-life of metformin in plasma is denoted by t1/2.

Original Secondary Outcome Measures (submitted: April 19, 2012)

• Number of participants with AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours ]
• Number of participants with tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
• Number of participants with t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• Drug: Linagliptin/metformin
  FDC
• Drug: Metformin
  single tablet Metformin
• Drug: Linagliptin
  single tablet Linagliptin

Study Arms

• Experimental: Linagliptin/metformin
  fixed dose combination tablet (FDC)
  Intervention: Drug: Linagliptin/metformin
• Experimental: Linagliptin and metformin
  single tablets
  Interventions:

  • Drug: Metformin
  • Drug: Linagliptin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2012): 32
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01581931
• Other Study ID Numbers: 1288.20; 2011-005423-41 ( EudraCT Number: EudraCT )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Boehringer Ingelheim
• Study Sponsor: Boehringer Ingelheim
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: June 2013