| Primary | Maximum Safinamide Plasma Concentration (Cmax) | The Cmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product (IMP) intake and had evaluable pharmacokinetic (PK) data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | Day 1 and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| | | Title | Denominators | Categories |
|---|
| Day 1 | | | Title | Measurements |
|---|
| - OG000411.5± 96.58
- OG001792.1± 124.0
|
| | Day 8 | | |
| |
| Primary | Time Corresponding to Occurrence of Cmax (Tmax) | The tmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Median | Full Range | hour (h) | | Day 1 and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Area Under the Concentration-time Curve From Single-dose Administration to the Last Quantifiable Concentration-time t (AUC0-t) | The (AUC0-t) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour* nanogram/milliliter (h*ng/mL) | | Day 1 and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Area Under the Concentration-time Curve in the Tau Interval (From Single Dose Administration to 24 h Post Dose) (AUC0-24h) | The (AUC0-24h) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour*nanogram/milliliter (h*ng/mL) | | Day 1 and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Last Quantifiable Concentration (Clast/Ct) | The (Clast/Ct) was determined on Day 1 (after the first dose) of safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Terminal Elimination Rate Constant (Kel) | Apparent terminal elimination rate constant, calculated, if feasible, from the slope of a log-linear regression using at least 3 last concentration > lower limit of quantification (LLOQ) points. The Kel was determined on Day 1 (after the first dose) of safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour (h) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Apparent Terminal Elimination Half Life (t1/2) | Apparent terminal elimination half-life, calculated, if feasible, as ln2/Kel. The t1/2 will be determined on Day 1 (after the first dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour (h) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) | The %AUCex was determined on Day 1 (after the first dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | percentage (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | AUC From Time Zero Extrapolated to Infinity (AUC(0-inf)) | Area under the concentration-time curve extrapolated to infinity, calculated, if feasible, as AUC0-t + Ct/Kel, where Ct is the last measurable drug concentration. The AUC(0-inf) was determined on day 1 (after the first dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour*nanogram/milliliter (h*ng/mL) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Apparent Volume of Distribution During Terminal Phase (Vd/F) | Apparent volume of distribution associated with the terminal slope, calculated, if feasible, as Dose/(AUC0-∞*Kel). The Vd/F was determined on Day 1 (after the first dose) of safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | milliliter (mL) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Apparent Clearance Following Oral Administration (CL/F) | Apparent total body clearance, calculated, if feasible, as Dose/AUC0-∞. The CL/F was determined on Day 1 (after the first dose) of safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | milliliter/ hour (mL/h) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Mean Residence Time (MRT) | Mean residence time, calculated, if feasible, as AUMC0-∞/AUC0-∞, where AUMC0-∞ is area under the moment concentration-time curve extrapolated to infinity. The MRT was determined on Day 1 (after the first dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour (h) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Area Under the First Moment of the Concentration-time Curve (AUMC) | The AUMC was determined on Day 1 (after the first dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour2* nanogram/milliliter (h2*ng/mL) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Maximum Safinamide Plasma Concentration at Steady State (Cmax_ss) | The Cmax_ss was determined on day 14 (after the multiple-dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | nnaogram/milliliter (ng/mL) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Time Corresponding to Occurrence of Cmax_ss at Steady State (tmax_ss) | The tmax_ss was determined on day 14 (after the multiple-dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Median | Full Range | hour (h) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Minimum Observed Concentration at Steady State (Cmin_ss) | The Cmin_ss was determined on day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | nanogram/liter (ng/mL) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Area Under the Concentration-time Curve at Steady State From the Last Dose Administration to the Last Observed Concentration Time t (AUC0-t_ss) | The AUC0-t_ss was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour*nanogram/milliliter (h*ng/mL) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | AUC Over the Dosing Interval at Steady State (AUC0-τ_ss) | The AUC0-τ_ss was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | hour*nanogram/milliliter (h*ng/mL) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Average Safinamide Plasma Concentration at Steady State(Cave_ss) | Average safinamide plasma concentration at steady state, calculated as AUC0- 24h_ss /tau (24 h). The Cave_ss was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Accumulation Ratio, Based on AUC (Racc,AUC) | Racc,AUC was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | ratio | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Accumulation Ratio, Based on Cmax (Racc,Cmax) | Racc,Cmax was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | ratio | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Peak-trough Fluctuation Over One Dosing Interval at Steady-state (DF%) | Peak-trough fluctuation over one dosing interval at steady-state, calculated as (Cmax,ss - Cmin,ss)/Cave,ss*100. The DF% was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | percentage (%) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Apparent Volume of Distribution at Steady-state Associated With the Terminal Slope (Vd/F_ss) | Apparent volume of distribution at steady-state associated with the terminal slope, calculated, if feasible, as Dose/( AUC0-24h_ss*Kel). The Vd/F_ss was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | milliliter (mL) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Primary | Apparent Total Body Clearance at Steady-state, (CL/F_ss) | The CL/F_ss was determined on Day 14 (after the multiple dose) of Safinamide. | All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses. | Posted | | Mean | Standard Deviation | milliliter/hour (mL/h) | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. | | OG001 | Cohort 2 (Safinamide 100mg) | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days. |
| |
| Secondary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | Safety and general tolerability were assessed for safinamide. | All randomised subjects who receive at least one dose of the investigational medicinal product(s). This analysis set will be used for the safety analyses. | Posted | | Count of Participants | | Participants | | Day 1 to18 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 (Safinamide 50mg) Single Dose | The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1). | | OG001 | Cohort 2 (Safinamide 100mg) Single Dose | The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1). | | OG002 | Cohort 1 (Safinamide 50mg) Multiple Dose | The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). | | OG003 | Cohort 2 (Safinamide 100mg) Multiple Dose | The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). |
|