NCT04095182

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Whanin Pharmaceutical Company · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Zebinix 400mg	Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)
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)
DRUG	Zebinix 800mg	Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5\~11)
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)
DRUG	Zebinix 1600mg	Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)
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)

Timeline

• Start date: 2019-08-22
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2019-09-19
• Last updated: 2020-01-07

Locations

1 site across 1 country: South Korea