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The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed dose combination | Experimental | Linagliptin/Metformin |
|
| Free combination | Experimental | Linagliptin and Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Free combination |
| |
| Linagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours) | Linagliptin: AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours) | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Metformin: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | Metformin: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Linagliptin: Cmax (maximum measured concentration of the analyte in plasma) | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Metformin: Cmax (maximum measured concentration of the analyte in plasma) | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | Linagliptin: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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Inclusion criteria:
Based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests (haematology, clinical chemistry and urinalysis).
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1288.21.1 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Dose Combination First, Then Free Combination | 5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets first; then free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet |
| FG001 | Free Combination First, Then Fixed Dose Combination | Free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet first; then 5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1 |
| |||||||||||||
| Test Period 2 |
|
Treated set (TS): includes all subjects who had been dispensed study medication and were documented to have taken at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects treated with 5 mg linagliptin / 1000 mg metformin as fixed dose combination or as free dose combination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours) | Linagliptin: AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours) | subject set for the evaluation of pharmacokinetic endpoints of linagliptin (PKS-L): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
From first study drug administration until 30±2 days after the last study drug administration
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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 | Fixed Dose Combination | Linagliptin/Metformin Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011687 |
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| Drug |
Fixed dose combination |
|
| Metformin | Drug | Combination |
|
| Linagliptin | Drug | Free combination |
|
| Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | Metformin: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Linagliptin: AUC 0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | Linagliptin: AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Free Combination | Linagliptin and Metformin Metformin: Free combination 5mg Linagliptin: Free combination 1000mg |
|
|
|
| Primary | Metformin: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | Metformin: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | The subject set for the evaluation of pharmacokinetic endpoints of metformin (PKS-M): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
|
|
|
| Primary | Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Linagliptin: Cmax (maximum measured concentration of the analyte in plasma) | PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
|
|
|
| Primary | Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Metformin: Cmax (maximum measured concentration of the analyte in plasma) | PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
|
|
|
| Secondary | Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | Linagliptin: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
|
|
|
| Secondary | Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | Metformin: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
|
|
|
| Secondary | Linagliptin: AUC 0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | Linagliptin: AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
|
|
|
| 0 |
| 36 |
| 1 |
| 36 |
| EG001 | Free Combination | Linagliptin and Metformin Metformin: Free combination 5mg Linagliptin: Free combination 1000mg | 0 | 36 | 4 | 36 |
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |