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

Whanin Pharmaceutical Company

Status and phase: Completed; Phase 1

Conditions: Partial-onset Seizures With or Without Secondary Generalisation

Treatments: Drug: Zebinix 800mg; Drug: Placebo for Zebinix 1600mg; Drug: Placebo for Zebinix 400mg; Drug: Zebinix 400mg; Drug: Zebinix 1600mg; Drug: Placebo for Zebinix 800mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04095182

WID-ESL18-P1

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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50 participants in 6 patient groups, including a placebo group

Zebinix 400mg

Experimental group

Treatment:

Drug: Zebinix 400mg

Placebo for Zebinix 400mg

Placebo Comparator group

Treatment:

Drug: Placebo for Zebinix 400mg

Zebinix 800mg

Experimental group

Treatment:

Drug: Zebinix 800mg

Placebo for Zebinix 800mg

Placebo Comparator group

Treatment:

Drug: Placebo for Zebinix 800mg

Zebinix 1600mg

Experimental group

Treatment:

Drug: Zebinix 1600mg

Placebo for Zebinix 1600mg

Placebo Comparator group

Treatment:

Drug: Placebo for Zebinix 1600mg