Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
2 other identifiers
interventional
32
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
August 20, 2013
CompletedAugust 20, 2013
June 1, 2013
2 months
April 19, 2012
June 14, 2013
June 14, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin
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.
0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
Maximum Concentration (Cmax) of Metformin
Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.
0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
Secondary Outcomes (3)
Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin
0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
Time to Maximum Concentration (Tmax) of Metformin
0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
Terminal Half-life t1/2 of Metformin
0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
Study Arms (2)
Linagliptin/metformin
EXPERIMENTALfixed dose combination tablet (FDC)
Linagliptin and metformin
EXPERIMENTALsingle tablets
Interventions
Eligibility Criteria
You may qualify if:
- \. Healthy male and female subjects
You may not qualify if:
- \. Any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1288.20.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 20, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 20, 2013
Results First Posted
August 20, 2013
Record last verified: 2013-06