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To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1186 | Experimental | Healthy subjects were administered a single dose of Edaravone oral suspension |
|
| MCI-186 | Active Comparator | Healthy subjects were administered a single dose of Edaravone intravenous formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1186 | Drug | Oral suspension |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone After Oral and Intravenous Administration | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. | |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase (AUC0-inf) of Unchanged Edaravone After Oral and Intravenous Administration | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. | |
| Maximum Plasma Concentration (Cmax) of Unchanged Edaravone After Oral and Intravenous Administration | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. | |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero up to 24 Hours (AUC0-24) |
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Inclusion Criteria:
Exclusion Criteria: Additional screening criteria check may apply for qualification:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33955162 | Derived | Shimizu H, Nishimura Y, Shiide Y, Yoshida K, Hirai M, Matsuda M, Nakamaru Y, Kato Y, Kondo K. Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1188-1197. doi: 10.1002/cpdd.952. Epub 2021 May 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Edaravone Oral Suspensione First, Then Edaravone IV Formulation | Period 1: a single dose of Edaravone oral suspension (105 mg) . Period 2: a single dose of Edaravone IV formulation (60 mg/60 min). |
| FG001 | Edaravone IV Formulation First, Then Edaravone Oral Suspension | Period 1: a single dose of Edaravone IV formulation (60 mg/60 min). Period 2: a single dose of Edaravone oral suspension (105 mg) . |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Edaravone Oral Suspensione First, Then Edaravone IV Formulation | Period 1: a single dose of Edaravone oral suspension (105 mg) . Period 2: a single dose of Edaravone IV formulation (60 mg/60 min). |
| BG001 | Edaravone IV Formulation First, Then Edaravone Oral Suspension |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone After Oral and Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng·h/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
|
Day 1 to Day 11
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edaravone Oral Suspension | Healthy subjects were administered a single dose of Edaravone oral suspension (105 mg) under fasted condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | Please email | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2019 | Mar 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2019 | Mar 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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| MCI-186 |
| Drug |
Intravenous formulation |
|
|
| The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24 hrs ; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75,2, 3, 4, 6, 8, 12 hrs; Day 2 at 24 hrs. |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Sampling Time-point (for All Time-points) (AUC0-all) | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Terminal Elimination Half-life (t1/2) | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Elimination Rate Constant From the Central Compartment (Kel) | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Mean Residence Time From Time Zero up to Infinity With Extrapolation of the Terminal Phase (MRT0-inf) of Unchanged Edaravone | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Total Clearance (CL) of Unchanged Edaravone After Intravenous Administration | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Volume of Distribution During Terminal Phase (Vz) of Unchanged Edaravone After Intravenous Administration | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Volume of Distribution at Steady State (Vss) of Unchanged Edaravone After Intravenous Administration | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Apparent Total Clearance (CL/F) of Unchanged Edaravone After Oral Administration | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Unchanged Edaravone After Oral Administration | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Apparent Volume of Distribution at Steady State (Vss/F) of Unchanged Edaravone After Oral Administration | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Cumulative Amount of Drug Excreted in Urine From Time Zero up to 48 Hours (Ae0-48) | Urine samples are collected: Day1 to 6. |
| Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 48 Hours (Ae0-48) | Urine samples are collected: Day1 to 6. |
| Renal Clearance (CLr) of Unchanged Edaravone | Urine samples are collected: Day1 to 6. |
| Bioavailability (F) of Unchanged Edaravone After Oral Administration | Bioavailability was calculated from ratio of AUC0-inf of unchanged edaravone after oral and intravenous administration. | PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hrs; Day 2 at 24 and 36 hrs; Day 3 at 48 hrs. IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75,2, 3, 4, 6, 8, 12 hrs; Day 2 at 24 and 36 hrs; Day 3 at 48hrs. |
| AUC0-t of Sulfate and Glucuronide Conjugates After Oral and Intravenous Administration | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| AUC0-inf of Sulfate and Glucuronide Conjugates After Oral and Intravenous Administration | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Cmax of Sulfate and Glucuronide Conjugates After Oral and Intravenous Administration | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
| Number of Participants With Adverse Events and Adverse Drug Reactions | Day 1 to 11 |
| NOT COMPLETED |
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Period 1: a single dose of Edaravone IV formulation (60 mg/60 min). Period 2: a single dose of Edaravone oral suspension (105 mg) . |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Edaravone IV Formulation | Healthy subjects were administered a single dose of Edaravone IV formulation (60 mg/60 min) under fasted condition. |
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| Primary | Area Under the Plasma Concentration Versus Time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase (AUC0-inf) of Unchanged Edaravone After Oral and Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng·h/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Primary | Maximum Plasma Concentration (Cmax) of Unchanged Edaravone After Oral and Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Median | Full Range | h | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero up to 24 Hours (AUC0-24) | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng·h/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24 hrs ; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75,2, 3, 4, 6, 8, 12 hrs; Day 2 at 24 hrs. |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Sampling Time-point (for All Time-points) (AUC0-all) | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng·h/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Terminal Elimination Half-life (t1/2) | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | h | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Elimination Rate Constant From the Central Compartment (Kel) | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | 1/h | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Mean Residence Time From Time Zero up to Infinity With Extrapolation of the Terminal Phase (MRT0-inf) of Unchanged Edaravone | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | h | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Total Clearance (CL) of Unchanged Edaravone After Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | L/h | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Volume of Distribution During Terminal Phase (Vz) of Unchanged Edaravone After Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | L | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Volume of Distribution at Steady State (Vss) of Unchanged Edaravone After Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | L | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Apparent Total Clearance (CL/F) of Unchanged Edaravone After Oral Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | L/h | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Apparent Volume of Distribution During Terminal Phase (Vz/F) of Unchanged Edaravone After Oral Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | L | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Apparent Volume of Distribution at Steady State (Vss/F) of Unchanged Edaravone After Oral Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | L | The date of dosing is defined as Day 1. Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Cumulative Amount of Drug Excreted in Urine From Time Zero up to 48 Hours (Ae0-48) | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | mg | Urine samples are collected: Day1 to 6. |
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| Secondary | Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 48 Hours (Ae0-48) | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | percentage of dose | Urine samples are collected: Day1 to 6. |
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| Secondary | Renal Clearance (CLr) of Unchanged Edaravone | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | L/h | Urine samples are collected: Day1 to 6. |
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| Secondary | Bioavailability (F) of Unchanged Edaravone After Oral Administration | Bioavailability was calculated from ratio of AUC0-inf of unchanged edaravone after oral and intravenous administration. | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | percentage bioavailability | PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hrs; Day 2 at 24 and 36 hrs; Day 3 at 48 hrs. IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75,2, 3, 4, 6, 8, 12 hrs; Day 2 at 24 and 36 hrs; Day 3 at 48hrs. |
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| Secondary | AUC0-t of Sulfate and Glucuronide Conjugates After Oral and Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng·h/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | AUC0-inf of Sulfate and Glucuronide Conjugates After Oral and Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng·h/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Cmax of Sulfate and Glucuronide Conjugates After Oral and Intravenous Administration | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Mean | Standard Deviation | ng/mL | The date of dosing is defined as Day 1. PO: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12 hrs; IV: Day 1 at pre-dose, 0.25, 0.5, 1, 1.083, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12 hrs; Both groups: Day 2 at 24, 36 hrs; Day 3 at 48 hrs. |
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| Secondary | Number of Participants With Adverse Events and Adverse Drug Reactions | This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone oral suspension group (PO => IV) with 21 subjects, and the advance administration of edaravone IV formulation group (IV => PO) with 21 subjects to investigate the bioequivalence between edaravone oral suspension and edaravone IV formulation. | Posted | Count of Participants | Participants | Day 1 to 11 |
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| 0 |
| 42 |
| 0 |
| 42 |
| 1 |
| 42 |
| EG001 | Edaravone IV Formulation | Healthy subjects were administered a single dose of Edaravone IV formulation (60 mg/60 min) under fasted condition. | 0 | 42 | 0 | 42 | 1 | 42 |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Glucuronide Conjugate |
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| Glucuronide Conjugate |
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| Glucuronide Conjugate |
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| Glucuronide Conjugate |
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| Glucuronide Conjugate |
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| Glucuronide Conjugate |
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| Glucuronide Conjugate |
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