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Study Objectives:
Phase I Study divided into 3 parts written as bellows.
Part I. Lozanoc 50mg single dose under fed condition vs Part 2. Lozanoc 50mg single dose under fasted condition vs Part 3. Sporanox 100mg single dose under fed condition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lozanoc 50mg | Experimental | Lozanoc 50mg, oral administration |
|
| Sporanox 100mg | Active Comparator | Sporanox 100mg, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lozanoc 50mg | Drug | Lozanoc 50mg single dose under fed and fasted condition |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 0~120 hour after medication |
| Measure | Description | Time Frame |
|---|---|---|
| tmax | 0~120 hour after medication | |
| AUCinf | 0~120 hour after medication |
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Inclusion Criteria:
Korean male volunteers in the age between 19 and 50 years old (inclusive)
Subject who are able to give signed informed consent
Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighting at least 50kg
Subject who are considered
Pre-study physical examination with no clinically significant abnormalities
No clinically significant medical history
Vital signs were to be within reference ranges, or if outside of the range, not deemed clinically significant in the opinion of the Investigator
Pre-study clinical laboratory findings were to be within reference range, or if outside of the range, not deemed clinically significant in the opinion of the Investigator
No clinically significant abnormalities in 12-lead ECG results
Agree to continue to use at least two accepted methods of birth control and not to donate sperm for at least 1 days before the first dosing, during the course of the study and for a period of 90days following the last dosing.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, M.D., Ph.D. | Department of Clinical Pharmacology and Therapeutics, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D002177 | Candidiasis |
| D006660 | Histoplasmosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sporanox 100mg |
| Drug |
Sporanox 100mg single dose under fed condition |
|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010879 |
| Piperazines |