| Primary | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Metformin) | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Metformin (Period 1) | In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Metformin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001460.83± NAStandard Error is adjusted geometric Standard Error = 1.05
- OG0011434.81± NAStandard Error is adjusted geometric Standard Error = 1.05
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Geometric means ratio | 98.22 | Standard Error of the Mean | 5.2 | 2-Sided | 90 | 94.89 | 101.67 | | | The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV). | | Other | ANOVA model including "subject" as random and "treatment" as fixed effect was used. | |
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| Primary | Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Rosuvastatin) | Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Rosuvastatin (Period 1) | In period 1 (Visit 2): 1 film-coated tablet of 10 milligrams (mg) Rosuvastatin was taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Rosuvastatin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 1 film-coated tablet of 10 mg Rosuvastatin was administered orally once. The two Rosuvastatin administrations were separated by a wash-out period of at least 14 days. |
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| Primary | Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Furosemide) | Area under the concentration-time curve of Furosemide in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Furosemide (Period 1) | In period 1 (Visit 2): 0.1 milliliter (mL) oral solution of 1 milligrams (mg) Furosemide were taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Furosemide + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.1 milliliter (mL) oral solution of 1 milligrams (mg) Furosemide were administered orally once. The two Furosemide administrations were separated by a wash-out period of at least 14 days. |
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| Primary | Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Digoxin) | Area under the concentration-time curve of Digoxin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
|---|
| OG000 | Digoxin (Period 1) | In period 1 (Visit 2): 1 tablet of 0.25 milligrams (mg) of Digoxin was taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Digoxin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 1 tablet of 0.25 mg Digoxin was administered orally once. The two Digoxin administrations were separated by a wash-out period of at least 14 days. |
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| Primary | Maximum Measured Concentration of Metformin in Plasma (Cmax, Metformin) | Maximum measured concentration of Metformin in plasma is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | nanomole / liter (nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Metformin (Period 1) | In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Metformin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days. |
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| Primary | Maximum Measured Concentration of Rosuvastatin in Plasma (Cmax, Rosuvastatin) | Maximum measured concentration of Rosuvastatin in plasma is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | nanomole / liter (nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
|---|
| OG000 | Rosuvastatin (Period 1) | In period 1 (Visit 2): 1 film-coated tablet of 10 milligrams (mg) Rosuvastatin was taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Rosuvastatin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 1 film-coated tablet of 10 mg Rosuvastatin was administered orally once. The two Rosuvastatin administrations were separated by a wash-out period of at least 14 days. |
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| Primary | Maximum Measured Concentration of Furosemide in Plasma (Cmax, Furosemide) | Maximum measured concentration of Furosemide in plasma is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Furosemide (Period 1) | In period 1 (Visit 2): 0.1 milliliter (mL) oral solution of 1 milligrams (mg) Furosemide were taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Furosemide + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.1 milliliter (mL) oral solution of 1 milligrams (mg) Furosemide were administered orally once. The two Furosemide administrations were separated by a wash-out period of at least 14 days. |
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| Primary | Maximum Measured Concentration of Digoxin in Plasma (Cmax, Digoxin) | Maximum measured concentration of Digoxin in plasma is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | nanomole / liter (nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Digoxin (Period 1) | In period 1 (Visit 2): 1 tablet of 0.25 milligrams (mg) of Digoxin was taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Digoxin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 1 tablet of 0.25 mg Digoxin was administered orally once. The two Digoxin administrations were separated by a wash-out period of at least 14 days. |
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| Secondary | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Metformin) | Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Metformin (Period 1) | In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Metformin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days. |
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| Secondary | Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Rosuvastatin) | Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h * nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Rosuvastatin (Period 1) | In period 1 (Visit 2): 1 film-coated tablet of 10 milligrams (mg) Rosuvastatin was taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Rosuvastatin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 1 film-coated tablet of 10 mg Rosuvastatin was administered orally once. The two Rosuvastatin administrations were separated by a wash-out period of at least 14 days. |
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| Secondary | Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Furosemide) | Area under the concentration-time curve of Furosemide in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
|---|
| OG000 | Furosemide (Period 1) | In period 1 (Visit 2): 0.1 milliliter (mL) oral solution of 1 milligrams (mg) Furosemide were taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Furosemide + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.1 milliliter (mL) oral solution of 1 milligrams (mg) Furosemide were administered orally once. The two Furosemide administrations were separated by a wash-out period of at least 14 days. |
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| Secondary | Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Digoxin) | Area under the concentration-time curve of Digoxin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean. | Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | | Geometric Mean | Standard Error | hour * nanomole / liter (h*nmol/L) | | 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2. | | | | ID | Title | Description |
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| OG000 | Digoxin (Period 1) | In period 1 (Visit 2): 1 tablet of 0.25 milligrams (mg) of Digoxin was taken orally as a single dose once on Day 1 of period 1 (Visit 2). | | OG001 | Digoxin + BI 730357 (Period 2) | In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 1 tablet of 0.25 mg Digoxin was administered orally once. The two Digoxin administrations were separated by a wash-out period of at least 14 days. |
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