A Phase 1 interventional study of Linagliptin + Pioglitazone and Linagliptin + Pioglitazone in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
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.
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy male and female subjects
Exclusion criteria:
Any relevant deviation from healthy conditions
Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
Drug: Linagliptin/Pioglitazone
Tablets, oral administration with 240 mL water for each treatment
Drug: Linagliptin + Pioglitazone
Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
Drug: Linagliptin/Pioglitazone
Tablets, oral administration with 240 mL water for each treatment
Drug: Linagliptin + Pioglitazone
Medium doses, oral administration
Medium doses, oral administration
Medium dose oral administration
Medium dose oral administration
AUC0-72 of Linagliptin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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 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
Time frame: 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
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
| Milestone | Sequence TRTR | Sequence RTRT |
|---|---|---|
| Started | 32 | 32 |
| Completed | 30 | 29 |
| Not completed | 2 | 3 |
| Withdrew: Adverse event | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours
| nmol*h/L | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| AUC0-72 of Linagliptin | 278 ± 20.6 | 279 ± 20.6 |
Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.
| nmol/L | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| Cmax of Linagliptin | 8.65 ± 33.3 | 9.09 ± 31.2 |
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
| ng*h/mL | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| AUC0-tz of Pioglitazone | 6370 ± 49.3 | 8100 ± 41.2 |
Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.
| ng/mL | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| Cmax of Pioglitazone | 806 ± 58.5 | 843 ± 42.7 |
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
| nmol*h/L | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| AUC0-tz for Linagliptin | 278 ± 20.6 | 279 ± 20.6 |
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin
| nmol*h/L | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| AUC0-∞ of Linagliptin | 455 ± 27.4 | 447 ± 24.5 |
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone
| ng*h/mL | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| AUC0-∞ of Pioglitazone | 6580 ± 47.5 | 8300 ± 40.4 |
Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin
| hours | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| Tmax for Linagliptin | 1.73 (0.667 to 6.93) | 1.50 (0.577 to 6.93) |
Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone
| hours | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| Tmax for Pioglitazone | 1.00 (0.667 to 5.66) | 1.50 (0.650 to 4.90) |
Collected over 4 days treatment period (one day for every single dose), 35 days washout between drug administrations. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FDC L5P30 (Test) | — | 0/62 (0%) | 13/62 (21%) |
| L5+P30 (Ref) | — | 1/63 (1.6%) | 7/63 (11.1%) |
| Event | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| Gastrointestinal painGastrointestinal disorders | 0/62 | 1/63 |
| Event | FDC L5P30 (Test) | L5+P30 (Ref) |
|---|---|---|
| HeadacheNervous system disorders | 9/62 | 5/63 |
| NasopharyngitisInfections and infestations | 5/62 | 3/63 |
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.
| Age, Continuous(years) | Sequence TRTR | Sequence RTRT | Total |
|---|---|---|---|
| Mean | 37.8 ± 8.8 | 38.0 ± 9.3 | 37.9 ± 9.0 |
| Sex: Female, Male(Participants) | Sequence TRTR | Sequence RTRT | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 19 | 19 | 38 |
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim