Healthy Adult Subjects
Conditions
Brief summary
To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.
Interventions
DRUGMT-1186
A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.
Sponsors
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who meet all of the following criteria and who have the capability of giving informed consent will be included in the study. 1. Healthy adult male or female volunteers 2. Japanese 3. Subjects aged between 20 and 45 years at the time of informed consent 4. Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study
Exclusion criteria
* Subjects who met any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Maximum Plasma Concentration (Cmax) of Edaravone | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Cmax of Sulfate Conjugate and Glucuronide Conjugate | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Mean Residence Time (MRT) of Unchanged Edaravone | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Apparent Total Clearance (CL/F) of Unchanged Edaravone | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration |
| Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Day 1 to 9, Day 24 to 26 |
| Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Day 1 to 9, Day 24 to 26 |
| Renal Clearance (CLr) of Unchanged Edaravone | Day 1 to 9, Day 24 to 26 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions | Day 1 to Day 31 |
Countries
Japan
Contacts
STUDY_DIRECTORShionogi Clinical Trials Administrator Clinical Support Help Line
Shionogi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.
MT-1186 orally dosing under fasted condition in period 1, dosing 8 hours after high-fat meal in period 2, dosing 4 hours after low-fat meal in period 3, dosing 2 hours after light meal in period 4, and dosing 2 hours after low-fat meal in period 5. | 4 |
| Group B A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.
MT-1186 orally dosing 8 hours after high-fat meal in period 1, dosing 4 hours after low-fat meal in period 2, dosing 2 hours after light meal in period 3, dosing under fasted condition in period 4 and dosing 2 hours after low-fat meal in period 5. | 4 |
| Group C A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.
MT-1186 orally dosing 4 hours after low-fat meal in period 1, dosing 2 hours after light meal in period 2, dosing under fasted condition in period 3, dosing 8 hours after high-fat meal in period 4 and dosing 2 hours after low-fat meal in period 5. | 4 |
| Group D A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.
MT-1186 orally dosing 2 hours after light meal in period 1, dosing under fasted condition in period 2, dosing 8 hours after high-fat meal in period 3, dosing 4 hours after low-fat meal in period 4 and dosing 2 hours after low-fat meal in period 5. | 4 |
| Total | 16 |
Baseline characteristics
| Characteristic | Group B | Group C | Group A | Group D | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 1 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | 608 L | Standard Deviation 247 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | 530 L | Standard Deviation 156 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | 646 L | Standard Deviation 239 |
| Edaravone Single Dose 2 Hours After a Light Meal | Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | 585 L | Standard Deviation 305 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone | 993 L | Standard Deviation 666 |
Primary
Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | 126.4 L | Standard Deviation 57.2 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | 114.2 L | Standard Deviation 46.7 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | 128.6 L | Standard Deviation 41.6 |
| Edaravone Single Dose 2 Hours After a Light Meal | Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | 136.1 L | Standard Deviation 59 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone | 231.4 L | Standard Deviation 84 |
Primary
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.0931 1/h | Standard Deviation 0.0343 |
| Edaravone Single Dose Under Fasting Condition | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.1690 1/h | Standard Deviation 0.0125 |
| Edaravone Single Dose Under Fasting Condition | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.1164 1/h | Standard Deviation 0.0249 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.1062 1/h | Standard Deviation 0.03 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.0999 1/h | Standard Deviation 0.0248 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.1720 1/h | Standard Deviation 0.0162 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.1221 1/h | Standard Deviation 0.0195 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.1010 1/h | Standard Deviation 0.0645 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.1699 1/h | Standard Deviation 0.0173 |
| Edaravone Single Dose 2 Hours After a Light Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.1108 1/h | Standard Deviation 0.033 |
| Edaravone Single Dose 2 Hours After a Light Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.1762 1/h | Standard Deviation 0.0254 |
| Edaravone Single Dose 2 Hours After a Light Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.1172 1/h | Standard Deviation 0.0246 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.1463 1/h | Standard Deviation 0.0266 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.0864 1/h | Standard Deviation 0.0435 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.1905 1/h | Standard Deviation 0.0176 |
Primary
Apparent Total Clearance (CL/F) of Unchanged Edaravone
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Apparent Total Clearance (CL/F) of Unchanged Edaravone | 53.0 L/h | Standard Deviation 16.3 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Apparent Total Clearance (CL/F) of Unchanged Edaravone | 51.4 L/h | Standard Deviation 14.4 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Apparent Total Clearance (CL/F) of Unchanged Edaravone | 55.1 L/h | Standard Deviation 16.9 |
| Edaravone Single Dose 2 Hours After a Light Meal | Apparent Total Clearance (CL/F) of Unchanged Edaravone | 57.9 L/h | Standard Deviation 17.6 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Apparent Total Clearance (CL/F) of Unchanged Edaravone | 65.4 L/h | Standard Deviation 17.3 |
Primary
Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone | 2165 ng·h/mL | Standard Deviation 673 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone | 2209 ng·h/mL | Standard Deviation 658 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone | 2073 ng·h/mL | Standard Deviation 641 |
| Edaravone Single Dose 2 Hours After a Light Meal | Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone | 1955 ng·h/mL | Standard Deviation 523 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone | 1717 ng·h/mL | Standard Deviation 463 |
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.931, 1.128]ANOVA
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.871, 1.056]ANOVA
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.827, 1.002]ANOVA
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.712, 0.901]ANOVA
Primary
AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 24519 ng·h/mL | Standard Deviation 7243 |
| Edaravone Single Dose Under Fasting Condition | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 4054 ng·h/mL | Standard Deviation 791 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 25724 ng·h/mL | Standard Deviation 7729 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 3895 ng·h/mL | Standard Deviation 796 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 24671 ng·h/mL | Standard Deviation 6077 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 4109 ng·h/mL | Standard Deviation 891 |
| Edaravone Single Dose 2 Hours After a Light Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 3914 ng·h/mL | Standard Deviation 841 |
| Edaravone Single Dose 2 Hours After a Light Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 25903 ng·h/mL | Standard Deviation 8657 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 26293 ng·h/mL | Standard Deviation 10355 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 4325 ng·h/mL | Standard Deviation 1054 |
Primary
Cmax of Sulfate Conjugate and Glucuronide Conjugate
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 8456 ng/mL | Standard Deviation 2041 |
| Edaravone Single Dose Under Fasting Condition | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 2283 ng/mL | Standard Deviation 496.2 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 9024 ng/mL | Standard Deviation 2430 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 2209 ng/mL | Standard Deviation 645.9 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 8629 ng/mL | Standard Deviation 1960 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 2283 ng/mL | Standard Deviation 486.7 |
| Edaravone Single Dose 2 Hours After a Light Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 2141 ng/mL | Standard Deviation 548.1 |
| Edaravone Single Dose 2 Hours After a Light Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 8665 ng/mL | Standard Deviation 2362 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 7986 ng/mL | Standard Deviation 2288 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Cmax of Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 2031 ng/mL | Standard Deviation 608.9 |
Primary
Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate
Time frame: Day 1 to 9, Day 24 to 26
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 13.87 mg | Standard Deviation 12.62 |
| Edaravone Single Dose Under Fasting Condition | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.819 mg | Standard Deviation 0.349 |
| Edaravone Single Dose Under Fasting Condition | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 144.6 mg | Standard Deviation 19.9 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 146.8 mg | Standard Deviation 20.5 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 13.10 mg | Standard Deviation 12.61 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 1.609 mg | Standard Deviation 2.63 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 144.0 mg | Standard Deviation 18.4 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 13.13 mg | Standard Deviation 13.99 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.977 mg | Standard Deviation 0.406 |
| Edaravone Single Dose 2 Hours After a Light Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 13.14 mg | Standard Deviation 10.96 |
| Edaravone Single Dose 2 Hours After a Light Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.988 mg | Standard Deviation 0.965 |
| Edaravone Single Dose 2 Hours After a Light Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 153.2 mg | Standard Deviation 22.6 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 160.2 mg | Standard Deviation 44.8 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 8.89 mg | Standard Deviation 9.5 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 1.302 mg | Standard Deviation 2.086 |
Primary
Maximum Plasma Concentration (Cmax) of Edaravone
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Maximum Plasma Concentration (Cmax) of Edaravone | 2318 ng/mL | Standard Deviation 1229 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Maximum Plasma Concentration (Cmax) of Edaravone | 2525 ng/mL | Standard Deviation 1337 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Maximum Plasma Concentration (Cmax) of Edaravone | 2020 ng/mL | Standard Deviation 1114 |
| Edaravone Single Dose 2 Hours After a Light Meal | Maximum Plasma Concentration (Cmax) of Edaravone | 1898 ng/mL | Standard Deviation 865.9 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Maximum Plasma Concentration (Cmax) of Edaravone | 1276 ng/mL | Standard Deviation 805.6 |
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.821, 1.429]ANOVA
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.661, 1.15]ANOVA
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.621, 1.082]ANOVA
Comparison: PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.90% CI: [0.362, 0.794]ANOVA
Primary
Mean Residence Time (MRT) of Unchanged Edaravone
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Mean Residence Time (MRT) of Unchanged Edaravone | 2.35 h | Standard Deviation 0.52 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Mean Residence Time (MRT) of Unchanged Edaravone | 2.19 h | Standard Deviation 0.49 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Mean Residence Time (MRT) of Unchanged Edaravone | 2.34 h | Standard Deviation 0.44 |
| Edaravone Single Dose 2 Hours After a Light Meal | Mean Residence Time (MRT) of Unchanged Edaravone | 2.32 h | Standard Deviation 0.54 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Mean Residence Time (MRT) of Unchanged Edaravone | 3.55 h | Standard Deviation 0.87 |
Primary
Renal Clearance (CLr) of Unchanged Edaravone
Time frame: Day 1 to 9, Day 24 to 26
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Renal Clearance (CLr) of Unchanged Edaravone | 0.419 L/h | Standard Deviation 0.271 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Renal Clearance (CLr) of Unchanged Edaravone | 0.818 L/h | Standard Deviation 1.413 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Renal Clearance (CLr) of Unchanged Edaravone | 0.535 L/h | Standard Deviation 0.333 |
| Edaravone Single Dose 2 Hours After a Light Meal | Renal Clearance (CLr) of Unchanged Edaravone | 0.545 L/h | Standard Deviation 0.535 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Renal Clearance (CLr) of Unchanged Edaravone | 0.871 L/h | Standard Deviation 1.582 |
Primary
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 8.17 h | Standard Deviation 2.29 |
| Edaravone Single Dose Under Fasting Condition | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 4.12 h | Standard Deviation 0.34 |
| Edaravone Single Dose Under Fasting Condition | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 6.32 h | Standard Deviation 1.85 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 7.16 h | Standard Deviation 2.52 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 7.38 h | Standard Deviation 1.97 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 4.07 h | Standard Deviation 0.41 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 5.85 h | Standard Deviation 1.18 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 9.05 h | Standard Deviation 5.07 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 4.12 h | Standard Deviation 0.46 |
| Edaravone Single Dose 2 Hours After a Light Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 7.31 h | Standard Deviation 4.3 |
| Edaravone Single Dose 2 Hours After a Light Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 4.03 h | Standard Deviation 0.7 |
| Edaravone Single Dose 2 Hours After a Light Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 6.25 h | Standard Deviation 1.69 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 4.91 h | Standard Deviation 1.02 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 11.25 h | Standard Deviation 8.35 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 3.67 h | Standard Deviation 0.34 |
Primary
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate
Time frame: Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.38 h |
| Edaravone Single Dose Under Fasting Condition | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.50 h |
| Edaravone Single Dose Under Fasting Condition | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.75 h |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.63 h |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.25 h |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.50 h |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.75 h |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.50 h |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.75 h |
| Edaravone Single Dose 2 Hours After a Light Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.38 h |
| Edaravone Single Dose 2 Hours After a Light Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.50 h |
| Edaravone Single Dose 2 Hours After a Light Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 0.75 h |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 1.00 h |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.50 h |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 0.75 h |
Primary
Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate
Time frame: Day 1 to 9, Day 24 to 26
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.780 % of dose | Standard Deviation 0.349 |
| Edaravone Single Dose Under Fasting Condition | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 68.7 % of dose | Standard Deviation 9.5 |
| Edaravone Single Dose Under Fasting Condition | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 9.08 % of dose | Standard Deviation 8.27 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 8.58 % of dose | Standard Deviation 8.26 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 1.533 % of dose | Standard Deviation 2.505 |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 69.7 % of dose | Standard Deviation 9.7 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 8.60 % of dose | Standard Deviation 9.17 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.931 % of dose | Standard Deviation 0.386 |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 68.4 % of dose | Standard Deviation 8.8 |
| Edaravone Single Dose 2 Hours After a Light Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 0.941 % of dose | Standard Deviation 0.919 |
| Edaravone Single Dose 2 Hours After a Light Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 72.8 % of dose | Standard Deviation 10.7 |
| Edaravone Single Dose 2 Hours After a Light Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 8.61 % of dose | Standard Deviation 7.18 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Sulfate conjugate | 5.82 % of dose | Standard Deviation 6.22 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Unchanged edaravone | 1.240 % of dose | Standard Deviation 1.986 |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate | Glucuronide conjugate | 76.1 % of dose | Standard Deviation 21.3 |
Secondary
Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Day 1 to Day 31
Population: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edaravone Single Dose Under Fasting Condition | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with Adverse events | 0 Participants |
| Edaravone Single Dose Under Fasting Condition | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with adverse drug reactions | 0 Participants |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with Adverse events | 0 Participants |
| Edaravone Single Dose 8 Hours After a High-fat Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with adverse drug reactions | 0 Participants |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with Adverse events | 1 Participants |
| Edaravone Single Dose 4 Hours After a Low-fat Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with adverse drug reactions | 0 Participants |
| Edaravone Single Dose 2 Hours After a Light Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with adverse drug reactions | 0 Participants |
| Edaravone Single Dose 2 Hours After a Light Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with Adverse events | 0 Participants |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with Adverse events | 0 Participants |
| Edaravone Single Dose 2 Hours After a Low-fat Meal | Number of Participants With Adverse Events and Adverse Drug Reactions | Number of Participants with adverse drug reactions | 0 Participants |