Status:
COMPLETED
Compare the Pharmacokinetic Characteristics and the Safety Between Zeropix and Champix in Healthy Adult Male Subjects.
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Smoking, Cigarette
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
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® tab...
Eligibility Criteria
Inclusion
- Healthy male older than 19 to 45 years at the time of screening
- Body weight more than 50kg and Body Mass Index(BMI) 18\~29 kg/m2 ☞ BMI = (weight \[kg\])/(height \[m\])2 3. Subject judged to be eligible by physical examination and interview conducted according to the study protocol. Thus, Subject should not have congenital/chronic disease or pathological symptoms/findings
Exclusion
- 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
- Aspartate Transaminase(AST) or Alanine Transaminase(ALT) \> 2 x upper limit of normal range
- Total Bilirubin \> 2.0 mg/dl
- CK \> 2 x upper limit of normal range
- eGFR \< 60 mL/min/1.73m2
- 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
Key Trial Info
Start Date :
July 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03362008
Start Date
July 6 2017
End Date
September 8 2017
Last Update
December 5 2017
Active Locations (1)
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1
Inha University Hospital
Incheon, South Korea