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To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single oral administration in healthy Korean male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| QDX 25 | Experimental |
| |
| QDX 50 | Experimental |
| |
| QDX 100 | Experimental |
| |
| QDX 200 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | Topiramate |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Capsaicin-Induced Dermal Blood Flow (DBF) | Change from Baseline in Dermal Blood Flow Induced by QDX Compared to Placebo | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1 |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]) | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. | 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 Last Quantifiable Plasma Concentration (AUClast) | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1 |
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1 |
| Time to Reach Maximum Plasma Concentration (Tmax) | Tmax was defined as the time required to reach maximum observed plasma concentration. | Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital, Dept. of Clinical Pharmacology | Seoul | South Korea |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| D009422 | Nervous System Diseases |
| Carbohydrates |
| D007661 | Ketoses |