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

A Single Center, Randomized, Double Blind, Placebo Controlled, Dose Escalation Clinical Trial to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX After Single Oral Administration in Healthy Korean Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04401137

Enrollment

Registered

2020-05-26

Start date

2020-07-01

Completion date

2020-10-06

Last updated

2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

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

Interventions

DRUGTopiramate

Topiramate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The Capsaicin-Induced Dermal Blood Flow (DBF)	Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1	Change from Baseline in Dermal Blood Flow Induced by QDX Compared to Placebo
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T])	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 the last quantifiable concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast)	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 last quantifiable concentration.
Maximum Observed Plasma Concentration (Cmax)	Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1	Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
Time to Reach Maximum Plasma Concentration (Tmax)	Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1	Tmax was defined as the time required to reach maximum observed plasma concentration.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026