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CompletedNCT01975220Updated Mar 8, 2017Results posted

Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets

A Phase 1 interventional study of Empagliflozin/Metformin XR, FDC and Empagliflozin/Metformin XR FDC in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males or females
  2. Age 18-50 years (incl)
  3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)
  4. Subjects must be able to understand and comply with study requirements

Exclusion criteria

Exclusion criteria:

Any deviation from healthy condition

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    High dose, fasted

    1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions

    Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC · Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

  • Experimental
    High dose, fed

    1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions

    Drug: Empagliflozin/Metformin XR, FDC · Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

  • Experimental
    Low dose, fasted

    2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions

    Drug: Empagliflozin/Metformin XR FDC · Drug: 1 tablet Empagliflozin/3 tablets Metformin XR

Interventions

  • DrugEmpagliflozin/Metformin XR, FDC

    Experimental: high dose empagliflozin/metformin XR, FDC tablet

  • DrugEmpagliflozin/Metformin XR FDC

    Experimental: low dose empagliflozin/metformin XR, FDC tablet

  • Drug25 mg Empagliflozin/1000 mg Metformin XR, FDC

    Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet

  • Drug1 tablet Empagliflozin/2 tablets Metformin XR

    Active Comparator: 1x empagliflozin/2x metformin XR tablets

  • Drug1 tablet Empagliflozin/3 tablets Metformin XR

    Active Comparator: 1x empagliflozin/3x metformin XR tablets

  • Drug1 tablet Empagliflozin/2 tablets Metformin XR

    Active Comparator: 1x empagliflozin/2x metformin XR tablets

06

What researchers measure

Primary outcomes

  1. Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin

    Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

  2. AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin

    AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

  3. Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin

    Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

  4. Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin

    Cmax (maximum measured concentration of the analyte in plasma); Metformin

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Secondary outcomes

  1. AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin

    AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

  2. AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin

    AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin

    Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

07

Results

Posted Mar 8, 2017

Participant flow

Test Period 1
Participant flow — Test Period 1
MilestoneHigh Dose, Fasted: 1 FDC Tablet First, Then 3 Single TabletsHigh Dose, Fasted: 3 Single Tablets First, Then 1 FDC TabletHigh Dose, Fed: 1 FDC Tablet First, Then 3 Single TabletsHigh Dose, Fed: 3 Single Tablets First, Then 1 FDC TabletLow Dose, Fasted: 2 FDC Tablets First, Then 4 Single TabletsLow Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets
Started121212121212
Completed121112121212
Not completed010000
Withdrew: Not treated010000
Test Period 2
Participant flow — Test Period 2
MilestoneHigh Dose, Fasted: 1 FDC Tablet First, Then 3 Single TabletsHigh Dose, Fasted: 3 Single Tablets First, Then 1 FDC TabletHigh Dose, Fed: 1 FDC Tablet First, Then 3 Single TabletsHigh Dose, Fed: 3 Single Tablets First, Then 1 FDC TabletLow Dose, Fasted: 2 FDC Tablets First, Then 4 Single TabletsLow Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets
Started121112121212
Completed121112121212
Not completed000000

Outcome measures

PrimaryArea Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin

Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin

Time frame:
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Reported as:
Geometric mean · nmol*h/L
Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin
nmol*h/LHigh Dose, Fasted: 1 FDC TabletHigh Dose, Fasted: 3 Single TabletsHigh Dose, Fed: 1 FDC TabletHigh Dose, Fed: 3 Single TabletsLow Dose, Fasted: 2 FDC TabletsLow Dose, Fasted: 4 Single Tablets
Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin6430 ± 22.36430 ± 21.75690 ± 21.05850 ± 19.67160 ± 19.57110 ± 20.5
Statistical analysis
  • High Dose, Fasted: 1 FDC Tablet vs High Dose, Fasted: 3 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 99.98 · 90% CI 97.275 to 102.751Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets'.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).
  • High Dose, Fed: 1 FDC Tablet vs High Dose, Fed: 3 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 97.09 · 90% CI 93.857 to 100.436The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • Low Dose, Fasted: 2 FDC Tablets vs Low Dose, Fasted: 4 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 100.70 · 90% CI 98.28 to 103.18The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
PrimaryAUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin

AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin

Time frame:
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Reported as:
Geometric mean · ng*h/mL
AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin
ng*h/mLHigh Dose, Fasted: 1 FDC TabletHigh Dose, Fasted: 3 Single TabletsHigh Dose, Fed: 1 FDC TabletHigh Dose, Fed: 3 Single TabletsLow Dose, Fasted: 2 FDC TabletsLow Dose, Fasted: 4 Single Tablets
AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin6350 ± 32.86700 ± 28.913000 ± 23.613100 ± 21.110200 ± 38.510300 ± 38.3
Statistical analysis
  • High Dose, Fasted: 1 FDC Tablet vs High Dose, Fasted: 3 Single Tablets · ANOVA · p = 0.0256 · Adjusted geometric mean ratio (%): 94.65 · 90% CI 82.29 to 108.88The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • High Dose, Fed: 1 FDC Tablet vs High Dose, Fed: 3 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 99.69 · 90% CI 96.25 to 103.26The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • Low Dose, Fasted: 2 FDC Tablets vs Low Dose, Fasted: 4 Single Tablets · ANOVA · p = 0.0020 · Adjusted geometric mean ratio (%): 99.76 · 90% CI 88.65 to 112.27The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
SecondaryAUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin

AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin

Time frame:
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Reported as:
Geometric mean · nmol*h/L
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin
nmol*h/LHigh Dose, Fasted: 1 FDC TabletHigh Dose, Fasted: 3 Single TabletsHigh Dose, Fed: 1 FDC TabletHigh Dose, Fed: 3 Single TabletsLow Dose, Fasted: 2 FDC TabletsLow Dose, Fasted: 4 Single Tablets
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin6510 ± 22.96490 ± 21.65800 ± 21.85970 ± 20.57240 ± 19.77180 ± 20.8
Statistical analysis
  • High Dose, Fasted: 1 FDC Tablet vs High Dose, Fasted: 3 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 100.10 · 90% CI 97.555 to 102.719The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • High Dose, Fed: 1 FDC Tablet vs High Dose, Fed: 3 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 97.01 · 90% CI 93.622 to 100.531The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • Low Dose, Fasted: 2 FDC Tablets vs Low Dose, Fasted: 4 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 100.78 · 90% CI 98.36 to 103.27The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
PrimaryCmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin

Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin

Time frame:
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Reported as:
Geometric mean · nmol/L
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin
nmol/LHigh Dose, Fasted: 1 FDC TabletHigh Dose, Fasted: 3 Single TabletsHigh Dose, Fed: 1 FDC TabletHigh Dose, Fed: 3 Single TabletsLow Dose, Fasted: 2 FDC TabletsLow Dose, Fasted: 4 Single Tablets
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin886 ± 27.3810 ± 28.1559 ± 29.0601 ± 25.01010 ± 27.0963 ± 29.7
Statistical analysis
  • High Dose, Fasted: 1 FDC Tablet vs High Dose, Fasted: 3 Single Tablets · ANOVA · p = 0.0072 · Adjusted geometric mean ratio (%): 109.07 · 90% CI 99.892 to 119.100The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • High Dose, Fed: 1 FDC Tablet vs High Dose, Fed: 3 Single Tablets · ANOVA · p = 0.0004 · Adjusted geometric mean ratio (%): 92.42 · 90% CI 86.781 to 98.428The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • Low Dose, Fasted: 2 FDC Tablets vs Low Dose, Fasted: 4 Single Tablets · ANOVA · p = 0.0014 · Adjusted geometric mean ratio (%): 105.37 · 90% CI 96.600 to 114.942The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
PrimaryCmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin

Cmax (maximum measured concentration of the analyte in plasma); Metformin

Time frame:
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Reported as:
Geometric mean · ng/mL
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin
ng/mLHigh Dose, Fasted: 1 FDC TabletHigh Dose, Fasted: 3 Single TabletsHigh Dose, Fed: 1 FDC TabletHigh Dose, Fed: 3 Single TabletsLow Dose, Fasted: 2 FDC TabletsLow Dose, Fasted: 4 Single Tablets
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin822 ± 37.4851 ± 28.81180 ± 27.41070 ± 22.81300 ± 34.41330 ± 41.3
Statistical analysis
  • High Dose, Fasted: 1 FDC Tablet vs High Dose, Fasted: 3 Single Tablets · ANOVA · p = 0.0198 · Adjusted geometric mean ratio (%): 96.65 · 90% CI 83.337 to 112.079The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • High Dose, Fed: 1 FDC Tablet vs High Dose, Fed: 3 Single Tablets · ANOVA · p = 0.0007 · Adjusted geometric mean ratio (%): 110.17 · 90% CI 103.809 to 116.926The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • Low Dose, Fasted: 2 FDC Tablets vs Low Dose, Fasted: 4 Single Tablets · ANOVA · p = 0.0037 · Adjusted geometric mean ratio (%): 97.68 · 90% CI 86.942 to 109.734The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
SecondaryAUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin

AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin

Time frame:
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Reported as:
Geometric mean · ng*h/mL
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin
ng*h/mLHigh Dose, Fasted: 1 FDC TabletHigh Dose, Fasted: 3 Single TabletsHigh Dose, Fed: 1 FDC TabletHigh Dose, Fed: 3 Single TabletsLow Dose, Fasted: 2 FDC TabletsLow Dose, Fasted: 4 Single Tablets
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin6490 ± 35.26790 ± 29.613200 ± 24.013200 ± 21.610500 ± 41.910400 ± 39.9
Statistical analysis
  • High Dose, Fasted: 1 FDC Tablet vs High Dose, Fasted: 3 Single Tablets · ANOVA · p = 0.0254 · Adjusted geometric mean ratio (%): 95.40 · 90% CI 82.42 to 110.44The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • High Dose, Fed: 1 FDC Tablet vs High Dose, Fed: 3 Single Tablets · ANOVA · p = <0.0001 · Adjusted geometric mean ratio (%): 99.63 · 90% CI 96.21 to 103.17The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).
  • Low Dose, Fasted: 2 FDC Tablets vs Low Dose, Fasted: 4 Single Tablets · ANOVA · p = 0.0029 · Adjusted geometric mean ratio (%): 101.06 · 90% CI 89.70 to 113.86The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).

Adverse events

Collected over From first trial medication intake until next intake or the end-of-trial visit, 10 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
High Dose, Fasted: 1 FDC Tablet—0/23 (0%)4/23 (17.4%)
High Dose, Fasted: 3 Single Tablets—0/23 (0%)1/23 (4.3%)
High Dose, Fed: 1 FDC Tablet—0/24 (0%)1/24 (4.2%)
High Dose, Fed: 3 Single Tablets—0/24 (0%)2/24 (8.3%)
Low Dose, Fasted: 2 FDC Tablets—0/24 (0%)4/24 (16.7%)
Low Dose, Fasted: 4 Single Tablets—0/24 (0%)1/24 (4.2%)
Most frequent other events
Most frequent other events
EventHigh Dose, Fasted: 1 FDC TabletHigh Dose, Fasted: 3 Single TabletsHigh Dose, Fed: 1 FDC TabletHigh Dose, Fed: 3 Single TabletsLow Dose, Fasted: 2 FDC TabletsLow Dose, Fasted: 4 Single Tablets
HeadacheNervous system disorders3/230/230/241/242/240/24
Abdominal painGastrointestinal disorders0/230/230/240/243/240/24
NauseaGastrointestinal disorders2/231/231/242/240/241/24

Baseline characteristics

Treated Set (TS): This patient set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug.

Age, Continuous
Age, Continuous(years)High Dose, FastedHigh Dose, FedLow Dose, FastedTotal
Mean32.4 ± 8.734.2 ± 9.230.8 ± 8.432.5 ± 8.8
Gender
Gender(Participants)High Dose, FastedHigh Dose, FedLow Dose, FastedTotal
Female10101030
Male13141441
08

Study locations

1 site
  • 1276.13.1 Boehringer Ingelheim Investigational Site
    Austin, Texas, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01975220
Lead sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 3, 2013
Start date
Oct 2013
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Mar 8, 2017
Last update
Mar 8, 2017

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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