Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult

NCT ID: NCT04095182

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2019-12-16

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

Conditions

Partial-onset Seizures With or Without Secondary Generalisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zebinix 400mg

Group Type: EXPERIMENTAL

Zebinix 400mg

Intervention Type: DRUG

Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Placebo for Zebinix 400mg

Group Type: PLACEBO_COMPARATOR

Placebo for Zebinix 400mg

Intervention Type: DRUG

Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day.

(Single dose: Day 1, Multiple dose: Day5~11)

Zebinix 800mg

Group Type: EXPERIMENTAL

Zebinix 800mg

Intervention Type: DRUG

Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Placebo for Zebinix 800mg

Group Type: PLACEBO_COMPARATOR

Placebo for Zebinix 800mg

Intervention Type: DRUG

Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day.

(Single dose: Day 1, Multiple dose: Day5~11)

Zebinix 1600mg

Group Type: EXPERIMENTAL

Zebinix 1600mg

Intervention Type: DRUG

Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Placebo for Zebinix 1600mg

Group Type: PLACEBO_COMPARATOR

Placebo for Zebinix 1600mg

Intervention Type: DRUG

Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day.

(Single dose: Day 1, Multiple dose: Day5~11)

Interventions

Zebinix 400mg

Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Intervention Type: DRUG

Placebo for Zebinix 400mg

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

Zebinix 800mg

Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Intervention Type: DRUG

Placebo for Zebinix 800mg

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

Zebinix 1600mg

Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Intervention Type: DRUG

Placebo for Zebinix 1600mg

Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day.

(Single dose: Day 1, Multiple dose: Day5~11)

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Whanin Pharmaceutical Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

In-Jin Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Whan In Pharm.

Seoul, , South Korea

Countries

South Korea

Other Identifiers

WID-ESL18-P1

Identifier Type: -

Identifier Source: org_study_id