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This is an open-label, randomized, crossover, single dose study. Two single doses of LC350189(tablet or capsule formulations) will be administered with a washout period of at least 4-day between the doses to investigate the relative bioavailability of LC350189 after administration via tablet formulation compared with capsule formulation and to evaluate basic systemic pharmacokinetic parameters of the tablet formulation compared to the capsule formulation of LC350189.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LC350189 Formulation A (Tablet) | Active Comparator | Each subject will be administered a single LC350189 200mg (QD) Tablet on Day 1 and Day 5, respectively. |
|
| LC350189 Formulation B (Capsule) | Active Comparator | Each subject will be administered two LC350189 100mg (QD) Capsules (2 x 100-mg capsules) on Day 1 or Day 5, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC350189 Tablet | Drug | Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The relative bioavailability of LC350189 after administration via tablet formulation compared with capsule formulation by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulation capsule formation | Blood sample for determination of plasma concentration of LC350189 will be collected at pre-dose and 0.5,1,2,4,6,8,16,24,36,48, and 72 hours | From baseline up to Day 8 (72 hours post on Day 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | Safety assessment | From baseline up to Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Las Vegas | Nevada | 89113 | United States |
To be determined
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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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| LC350189 Capsule | Drug | Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5 |
|
|
| 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 |