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

NCT ID: NCT04401137

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-10-06

Brief Summary

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

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Topiramate

Intervention Type DRUG

Topiramate

QDX 25

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

Topiramate

QDX 50

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

Topiramate

QDX 100

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

Topiramate

QDX 200

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

Topiramate

Interventions

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Topiramate

Topiramate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital, Dept. of Clinical Pharmacology

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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QDX001

Identifier Type: -

Identifier Source: org_study_id