| Primary | Dose-normalized Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) normalized to the actual administered dose is presented. The AUC0-tz was divided by the actual dose strength to get the normalized area under the concentration-time curve. The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Unit of measure:(hour*nanogram/milliliter)/milligram. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Geometric Least Squares Mean | Standard Error | (h*ng/mL)/mg | | Within 5 minutes (min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| - OG000117.15± NAThe standard error is actually the geometric standard error and is equal to 1.04.
- OG001116.65± NAThe standard error is actually the geometric standard error and is equal to 1.04.
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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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| The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | ANOVA | | 0.7792 | | Ratio of GLSM (%) | 99.57 | Standard Deviation | 5.23 | 2-Sided | 90 | 97.03 | 102.19 | | | Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A). Standard deviation is actually intra-individual geometric coefficient of variation (gCV [%]). |
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| Primary | Dose-normalized Maximum Measured Concentration of Empagliflozin (Cmax) | Dose-normalized Maximum measured concentration of empagliflozin in plasma is presented. The maximum measured concentration was divided by the actual dose strength to get the dose-normalised Cmax. The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. The unit of measure reported is: (nanogram/milliliter)/milligram. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Geometric Least Squares Mean | Standard Error | (ng/mL)/mg | | Within 5 minutes (min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Primary | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Geometric Least Squares Mean | Standard Error | hour*nanogram/milliliter (h*ng/mL) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
|---|
| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Primary | Maximum Measured Concentration of Metformin (Cmax) | Maximum measured concentration of metformin in plasma is presented. The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Geometric Least Squares Mean | Standard Error | nanogram/milliliter (ng/mL ) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | |
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| Secondary | Dose-normalized Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ ) | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity from the last quantifiable data point (AUC0-inf) normalized to the actual administered dose is presented. The AUC0-oo was divided by the actual dose strength to get the normalized area under the concentration-time curve. The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Unit of measure: (hour*nanogram/milliliter)/milligram. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Geometric Least Squares Mean | Standard Error | (h*ng/mL)/mg | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) |
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| Secondary | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞ ) is presented. The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Geometric Least Squares Mean | Standard Error | hour*nanogram/milliliter (hr*ng/mL) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
|---|
| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Time From Last Dosing to the Maximum Measured Concentration of Empagliflozin in Plasma (Tmax) | Time from last dosing to the maximum measured concentration of empagliflozin in plasma (tmax) is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Median | Full Range | Hours (hr) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Time From Last Dosing to the Maximum Measured Concentration of Metformin in Plasma (Tmax) | Time from last dosing to the maximum measured concentration of metformin in plasma (tmax) is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Median | Full Range | Hours (hr) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Percentage (%) of the AUC of Empagliflozin That Has Been Derived After Extrapolation | The percentage (%) of the AUC of empagliflozin that has been derived after extrapolation is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Mean | Standard Deviation | Percentage (%) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Percentage (%) of the AUC of Metformin That Has Been Derived After Extrapolation | The percentage (%) of the AUC of metformin that has been derived after extrapolation is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Mean | Standard Deviation | Percentage (%) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Terminal Half-life of Empagliflozin in Plasma (t1/2) | The terminal half-life of empagliflozin in plasma (t1/2) is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Median | Full Range | Hours (hr) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empaglifozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Terminal Half-life of Metformin in Plasma (t1/2) | The terminal half-life of metformin in plasma (t1/2) is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Median | Full Range | Hours (hr) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Elimination Rate Constant (Kel) for Empagliflozin | The elimination rate constant (Kel) for empagliflozin is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Mean | Standard Deviation | 1/hours (1/hr) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
|---|
| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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| Secondary | Elimination Rate Constant (Kel) for Metformin | The elimination rate constant (Kel) for metformin is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects who provided all PK endpoints for all treatment periods that were defined as primary (Cmax and AUCo-tz) and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Only subjects with non-missing values were included. | Posted | | Mean | Standard Deviation | 1/hours (1/hr) | | Within 5 minutes(min) before and 15min, 30min, 45min, 1h, 1h15min, 1h30min, 1h45min, 2h, 2h20min, 2h40min, 3h, 3h30min, 4h, 4h30min, 5h, 5h30min, 6h, 7h, 8h, 10h, 12h, 24h, 48h, and 72h after treatment administration for both arms. | | | | ID | Title | Description |
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| OG000 | (A): Empagliflozin 10mg (R1) + Metformin (Glifage®) 850mg (R2) | Participants received treatment A: Single dose tablet of 10 milligram (mg) empagliflozin film-coated and a 850mg of metformin HCl (Glifage®) tablet, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. | | OG001 | (B): FDC 12.5mg Empagliflozin/850mg Metformin | Participants were administered the treatment B which consisted of a single Fixed dose combination (FDC) tablet containing 12.5 milligram (mg) empagliflozin/850 mg metformin HCl, orally with 200 milliliter (mL) of water. A high-fat, high-calorie meal was served 30 minutes (min) before drug administration. |
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