Status:
COMPLETED
The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Migraine
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single oral administration in healthy Korean male subjects
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04401137
Start Date
July 1 2020
End Date
October 6 2020
Last Update
October 27 2020
Active Locations (1)
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1
Seoul National University Hospital, Dept. of Clinical Pharmacology
Seoul, South Korea