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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005423-41 | EudraCT Number | EudraCT |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin/metformin | Experimental | fixed dose combination tablet (FDC) |
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| Linagliptin and metformin | Experimental | single tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin/metformin | Drug | FDC |
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| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin | 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. | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |
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Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1288.20.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lina+Met Single Tablets / Lina+Met FDC Tablet | Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in the first period. After a washout period of at least 35 days, the subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in period 2. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Period |
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| Drug |
single tablet Metformin |
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| Linagliptin | Drug | single tablet Linagliptin |
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| Time to Maximum Concentration (Tmax) of Metformin |
Time from dosing to the maximum concentration of metformin in plasma. |
| 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 | The terminal half-life of metformin in plasma is denoted by t1/2. | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |
| Lina+Met FDC Tablet / Lina+Met Single Tablets |
Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in the first period. After a washout period of at least 35 days, the subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in period 2. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout |
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| Second Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This was an open-label, randomised, single dose, 2-way crossover trial with 2 treatments and 2 treatment sequences. The single dose administrations in each treatment period were separated by a washout period of at least 35 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Secondary | Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin | 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. | Treated set - all subjects taking at least 1 dose of trial medication | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |
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| Secondary | Time to Maximum Concentration (Tmax) of Metformin | Time from dosing to the maximum concentration of metformin in plasma. | Treated set - all subjects taking at least 1 dose of trial medication | Posted | Median | Full Range | Hours | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |
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| Secondary | Terminal Half-life t1/2 of Metformin | The terminal half-life of metformin in plasma is denoted by t1/2. | Treated set - all subjects taking at least 1 dose of trial medication | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |
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| Primary | 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. | Treated set - all subjects taking at least 1 dose of trial medication | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |
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| Primary | Maximum Concentration (Cmax) of Metformin | Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean. | Treated set - all subjects taking at least 1 dose of trial medication | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |
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First treatment with study drug until End-of-Study (which was within 4 to 14 days after last study drug administration), i.e., 39 to 49 days after first treatment with study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lina+Met Single Tablets | Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets | 0 | 31 | 6 | 31 | ||
| EG001 | Lina+Met FDC Tablet | Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet | 1 | 32 | 9 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle fracture | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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