ClinicalTrials.Veeva

Menu

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

S

SK chemicals

Status and phase

Completed
Phase 1

Conditions

Migraine

Treatments

Drug: Topiramate

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Topiramate
QDX 25
Experimental group
Treatment:
Drug: Topiramate
QDX 50
Experimental group
Treatment:
Drug: Topiramate
QDX 100
Experimental group
Treatment:
Drug: Topiramate
QDX 200
Experimental group
Treatment:
Drug: Topiramate

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems