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This study is a randomized, open-label, 2-way, 2-period, single-dose crossover clinical study to compare the pharmacokinetic characteristics and the safety between zeropix tablet 1 mg and champix® tablet 1 mg in healthy adult male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Period I: administration of Zeropix Period II: administration of Champix® |
|
| Group II | Experimental | Period I: administration of Champix® Period II: administration of Zeropix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zeropix | Drug | administration of Zeropix |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of Varenicline | 96 hours | |
| Cmax of Varenicline | 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
Subject currently with or has a history of cardiovascular , respiratory, hepatic, renal, neurological, endocrine, hemato-oncology, psychiatric, urinary diseases that is clinically significant
Subject with a history of significant hypersensitivity or clinically significant hypersensitivity reaction to varenicline and other drugs (aspirin, antibiotic…etc.)
Systolic blood pressure ⩽100mmHg or ⩾ 150mmHg, diastolic blood pressure⩽55mmHg or ⩾ 95mmHg
Subject with a history of gastrointestinal disease (i.e. Crohn's disease, ulcer…etc.) or gastrointestinal surgery (not including, simple appendectomy or hernia surgery) that can affect drug absorption
Subject with the following results in the clinical laboratory tests
Subject who takes alcohol > 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can't stop drinking during the clinical trials
Subject who smokes> 10 cigarettes/day or can't stop smoking during the clinical trials
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | South Korea |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Champix® |
| Drug |
administration of Champix® |
|
| D011810 | Quinoxalines |