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

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: Topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04401137

QDX001

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

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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