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This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group (reference drug → test drug) | Experimental | Participants receive the SKI-O-703 API in capsules 100mg (reference drug) in Period 1 and the SKI-O-703 Formulated Granules in capsules 200mg (test drug) in Period 2 under fed conditions, with a 7-day washout between periods. |
|
| B group ( test drug → reference drug) | Experimental | Participants receive the SKI-O-703 Formulated Granules in capsules 200mg (test drug) in Period 1 and the SKI-O-703 API in capsules 100mg (reference drug) in Period 2 under fed conditions, with a 7-day washout between periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKI-O-703 API in Capsules | Drug | SKI-O-703 API in Capsules 100mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure AUCt of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year | |
| To measure Cmax of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To measure Tmax of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year | |
| To measure t1/2 of SKI-O-592 (the free base of SKI-O-703) | Approximately 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
10) Smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarrets, or inhalers) within 30 days before the first dose of study drug or who tested positive for cotinine(indicating active current smoking) at screening or check-in (Day -1) 11) Individuals with hypersensitive to investigational product or components of investigational product 12) A women who are pregnant or suspected of being pregnant or breastfeeding. 13) Participants who do not consent to use medically acceptable methods of contraception* to eliminate the possibility of pregnancy from the date of the first dose until 1 month after the last dose of the study drug.
*Combined use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or a combination of at least two barrier methods with spermicide.
14) Individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunsil Lee Team Lead | Contact | 82316287627 | cd@oscotec.com | |
| Youjin Hwang Clinical Manager | Contact | yjhwang@oscotec.com |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| SKI-O-703 Formulated Granules in Capsules | Drug | SKI-O-703 Formulated Granules in Capsules 200mg |
|
| To measure Tmax of M2 and M4 |
| Approximately 1 year |
| To measure t1/2 of M2 and M4 | Approximately 1 year |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |