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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022649-29 | EudraCT Number | EudraCT |
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The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Linagliptin/Pioglitazone (Test) | Experimental | Fixed-Dose-Combination-Tablet, oral administration with 240 mL water |
|
| 2 Linagliptin + Pioglitazone (Ref) | Experimental | Tablets, oral administration with 240 mL water for each treatment |
|
| 3 Linagliptin/Pioglitazone (Test) | Experimental | Fixed-Dose-Combination-Tablet, oral administration with 240 mL water |
|
| 4 Linagliptin + Pioglitazone (Ref) | Experimental | Tablets, oral administration with 240 mL water for each treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin + Pioglitazone | Drug | Medium doses, oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72 of Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| Cmax of Linagliptin | Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported. | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| AUC0-tz of Pioglitazone | 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 | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| Cmax of Pioglitazone | Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated. | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz for Linagliptin | 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 for Linagliptin | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| AUC0-∞ of Linagliptin |
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Inclusion criteria:
Healthy male and female subjects
Exclusion criteria:
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 |
|---|---|---|---|---|---|---|
| 1264.14.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence TRTR | Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR. |
| FG001 | Sequence RTRT | Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
TS - The treated set included all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence TRTR | Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR. |
| BG001 |
| 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 | AUC0-72 of Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
4 days treatment period (one day for every single dose), 35 days washout between drug administrations
Treated set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of any study drug. Drug administrations were separated by washout periods of at least 35 days.
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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 | FDC L5P30 (Test) | Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal pain | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 14.0 | 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 |
|---|---|
| D000069476 | Linagliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Linagliptin + Pioglitazone |
| Drug |
Medium doses, oral administration |
|
| Linagliptin/Pioglitazone | Drug | Medium dose oral administration |
|
| Linagliptin/Pioglitazone | Drug | Medium dose oral administration |
|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin |
| 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| AUC0-∞ of Pioglitazone | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| Tmax for Linagliptin | Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| Tmax for Pioglitazone | Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
| Sequence RTRT |
Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast |
|
|
|
| Primary | Cmax of Linagliptin | Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported. | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
|
| Primary | AUC0-tz of Pioglitazone | 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 - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
|
| Primary | Cmax of Pioglitazone | Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated. | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
|
| Secondary | AUC0-tz for Linagliptin | 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 for Linagliptin | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
|
| Secondary | AUC0-∞ of Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
|
| Secondary | AUC0-∞ of Pioglitazone | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
|
| Secondary | Tmax for Linagliptin | Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Median | Full Range | hours | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
| Secondary | Tmax for Pioglitazone | Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone | PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period. | Posted | Median | Full Range | hours | 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours) |
|
|
|
| 0 |
| 62 |
| 13 |
| 62 |
| EG001 | L5+P30 (Ref) | Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast | 1 | 63 | 7 | 63 |
| Headache | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
|
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| D011799 | Quinazolines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |