The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects

SK Chemicals Co., Ltd.42 enrolled

Overview

To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single oral administration in healthy Korean male subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Migraine

Interventions

TopiramateDRUG

Topiramate

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who have fully understood this clinical trial via detailed explanation, are willing to voluntarily participate in this study, and agree to give written informed consent which is confirmed from IRB. * Healthy male participants aged between 19 and 45 years at screening * Those whose body weight is over 50kg, and BMI is between 18.0 and 27.0 * Participants who have demonstrated at least a 100 percent (%) increase in dermal blood flow in 30 minutes after capsaicin challenge as part of the screening procedures. Exclusion Criteria: * Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system, or history of those diseases * Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Topiramate etc.) * Those who have a hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome * Those who have irritating skin, wounds, eczema, and wounds on the area where capsaicin is applied

Locations (1)

Seoul National University Hospital, Dept. of Clinical Pharmacology

Seoul, South Korea

Outcomes

Primary Outcomes

The Capsaicin-Induced Dermal Blood Flow (DBF)

Change from Baseline in Dermal Blood Flow Induced by QDX Compared to Placebo

Time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T])

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.

Time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast)

Area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

Time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1

Maximum Observed Plasma Concentration (Cmax)

Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.

Time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1

Time to Reach Maximum Plasma Concentration (Tmax)

Tmax was defined as the time required to reach maximum observed plasma concentration.

Time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1

Data from ClinicalTrials.gov

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