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This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in combination in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Experimental | Period 1: LC350189 200mg (QD) Day 1~ Day 4, Period 2: Naproxen 500 mg (BID) Day 8 ~ Day 12 , Period 3 : LC350189 200mg (QD) + Naproxen 500 mg (BID) Day 13~19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanthine Oxidase Inhibitor | Drug | LC350189 200mg qd |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma | Pharmacokinetic | From baseline up to Day 18 |
| Area under the concentration-time curve (AUC) of LC350189 and Naproxen from plasma | Pharmacokinetic | From baseline up to Day 18 |
| Apparent terminal half-life (t1/2) of LC350189 and Naproxen from plasma | Pharmacokinetic | From baseline up to Day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | Safety | From baseline up to Day 18 |
| Changes in concentration of uric acid in plasma by uricase method | Pharmacodynamic |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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| nonsteroidal anti-inflammatory drug | Drug | Naproxen 500mg BID |
|
|
| From baseline up to Day 17 |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |