Back to resultsClinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult
Primary Purpose
Partial-onset Seizures With or Without Secondary Generalisation
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zebinix 400mg
Placebo for Zebinix 400mg
Zebinix 800mg
Placebo for Zebinix 800mg
Zebinix 1600mg
Placebo for Zebinix 1600mg
Sponsored by
About this trial
This is an interventional treatment trial for Partial-onset Seizures With or Without Secondary Generalisation
Eligibility Criteria
Inclusion Criteria:
- Healthy adult volunteers aged 19-45 years at screening
- Subjects who weigh more than 50kg with a body mass index(BMI) of 18.0~28.0 kg/m2 at screening
- Subjects who are fully understood after being given the detailed explanation of this clinical trial and willing to give written informed consent for participation prior to the screening test
- Subjects who are qualified to participate in this clinical trial through the physical examination, clinical laboratory test and interview by the investigators
Exclusion Criteria:
- Clinically significant presence or treatment history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, neurological, hematological, endocrine, psychiatric
- Clinically significant surgical history
- Clinically significant family history
- Clinically significant atopic syndrome
- History of hypersensitivity or clinically significant hypersensitivity to drug including carbamazepine and related compounds
- History of alcoholism or drug abuse or show a positive response to an abuse drug in the urine drug screening test
- Consistently consume alcohol or cannot stop drinking during the clinical trial
- Smoker
- Significant infection or inflammatory finding at screening visit
- History of gastrointestinal disorders or surgery which may have an effect on the safety and pharmacokinetic evaluation of the investigational products (except for simple appendectomy and herniotomy)
- Have used prescription drugs or herbal medication within 2 weeks of initial administration or who have used over the counter(OTC), health functional food or vitamins within 1 week of initial administration (but, if the other conditions are suitable according to the judgment of the investigator, they can participate in the clinical trial), or subjects who have expected to take it
- Have participated in any clinical trial (or bioequivalence study) and administered any investigational product within 6 months
- Positive for HbsAg, anti-HCV and HIV antigen-antibody reaction tests at screening
- Have donated any whole blood or apheresis or received blood transfusion within 3 months of initial administration of this clinical trial
- Have dietary restrictions or cannot take the food provided by the institution
- Cannot communicate reliably with the investigator
- Subjects who are determined by the investigator to be ineligible for participation in this clinical trial due to clinical laboratory test results or other reasons
Sites / Locations
- Whan In Pharm.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Zebinix 400mg
Placebo for Zebinix 400mg
Zebinix 800mg
Placebo for Zebinix 800mg
Zebinix 1600mg
Placebo for Zebinix 1600mg
Arm Description
Outcomes
Primary Outcome Measures
Time of maximum observed drug concentration (Tmax)
Maximum observed plasma drug concentration (Cmax)
Area under the plasma concentration time-curve (AUC)
Apparent terminal elimination half-life (t1/2)
Peak trough fluctuation (PTF)
Accumulation ratio (R)
Metabolic ratio
Secondary Outcome Measures
Adverse event
Full Information
NCT ID
NCT04095182
First Posted
September 15, 2019
Last Updated
January 6, 2020
Sponsor
Whanin Pharmaceutical Company
1. Study Identification
Unique Protocol Identification Number
NCT04095182
Brief Title
Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult
Official Title
A Dose Randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of Zebinix (Eslicarbazepine Acetate) After Oral Administration in Healthy Korean and Caucasian Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Whanin Pharmaceutical Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A dose randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase I clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of Zebinix (Eslicarbazepine acetate) after oral administration in healthy Korean and Caucasian adult subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial-onset Seizures With or Without Secondary Generalisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zebinix 400mg
Arm Type
Experimental
Arm Title
Placebo for Zebinix 400mg
Arm Type
Placebo Comparator
Arm Title
Zebinix 800mg
Arm Type
Experimental
Arm Title
Placebo for Zebinix 800mg
Arm Type
Placebo Comparator
Arm Title
Zebinix 1600mg
Arm Type
Experimental
Arm Title
Placebo for Zebinix 1600mg
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zebinix 400mg
Intervention Description
Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Intervention Type
Drug
Intervention Name(s)
Placebo for Zebinix 400mg
Intervention Description
Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11)
Intervention Type
Drug
Intervention Name(s)
Zebinix 800mg
Intervention Description
Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5~11)
Intervention Type
Drug
Intervention Name(s)
Placebo for Zebinix 800mg
Intervention Description
Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11)
Intervention Type
Drug
Intervention Name(s)
Zebinix 1600mg
Intervention Description
Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
Intervention Type
Drug
Intervention Name(s)
Placebo for Zebinix 1600mg
Intervention Description
Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day.
(Single dose: Day 1, Multiple dose: Day5~11)
Primary Outcome Measure Information:
Title
Time of maximum observed drug concentration (Tmax)
Time Frame
'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Title
Maximum observed plasma drug concentration (Cmax)
Time Frame
'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Title
Area under the plasma concentration time-curve (AUC)
Time Frame
'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Title
Apparent terminal elimination half-life (t1/2)
Time Frame
'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Title
Peak trough fluctuation (PTF)
Time Frame
'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Title
Accumulation ratio (R)
Time Frame
'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Title
Metabolic ratio
Time Frame
'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Secondary Outcome Measure Information:
Title
Adverse event
Time Frame
Day -1 ~ Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult volunteers aged 19-45 years at screening
Subjects who weigh more than 50kg with a body mass index(BMI) of 18.0~28.0 kg/m2 at screening
Subjects who are fully understood after being given the detailed explanation of this clinical trial and willing to give written informed consent for participation prior to the screening test
Subjects who are qualified to participate in this clinical trial through the physical examination, clinical laboratory test and interview by the investigators
Exclusion Criteria:
Clinically significant presence or treatment history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, neurological, hematological, endocrine, psychiatric
Clinically significant surgical history
Clinically significant family history
Clinically significant atopic syndrome
History of hypersensitivity or clinically significant hypersensitivity to drug including carbamazepine and related compounds
History of alcoholism or drug abuse or show a positive response to an abuse drug in the urine drug screening test
Consistently consume alcohol or cannot stop drinking during the clinical trial
Smoker
Significant infection or inflammatory finding at screening visit
History of gastrointestinal disorders or surgery which may have an effect on the safety and pharmacokinetic evaluation of the investigational products (except for simple appendectomy and herniotomy)
Have used prescription drugs or herbal medication within 2 weeks of initial administration or who have used over the counter(OTC), health functional food or vitamins within 1 week of initial administration (but, if the other conditions are suitable according to the judgment of the investigator, they can participate in the clinical trial), or subjects who have expected to take it
Have participated in any clinical trial (or bioequivalence study) and administered any investigational product within 6 months
Positive for HbsAg, anti-HCV and HIV antigen-antibody reaction tests at screening
Have donated any whole blood or apheresis or received blood transfusion within 3 months of initial administration of this clinical trial
Have dietary restrictions or cannot take the food provided by the institution
Cannot communicate reliably with the investigator
Subjects who are determined by the investigator to be ineligible for participation in this clinical trial due to clinical laboratory test results or other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whan In Pharm.
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult
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