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

Others

(Compare the Pharmacokinetic Characteristics and the Safety Between Zeropix and Champix in Healthy Adult Male Subjects)

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

Arm Label

Target Number of Participant

Arm Type

Arm Description

Period 1: Zeropix 1mg single dosing
Period 2: Champix 1mg single dosing

Arm Label

Target Number of Participant

Arm Type

Arm Description

Period 1: Champix 1mg single dosing
Period 2: Zeropix 1mg single dosing

Gender

Age

Description

1) Healthy male older than 19 to 45 years at the time of screening 
2) 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 
4. Subject judged to be eligible by clinical tests such as hematology test, blood chemistry test, serum electrolyte test, urine test, Urine Microscopy urine test, serology test performed according to the study protocol 
5. Subject who fully understands the clinical trials after in-depth explanation, volunteers to join the clinical trials and signs inform consent   

1) Subject currently with or has a history of cardiovascular , respiratory, hepatic, renal, neurological, endocrine, hemato-oncology, psychiatric, urinary diseases that is clinically significant 
2) Subject with a history of significant hypersensitivity or clinically significant hypersensitivity reaction to varenicline and other drugs (aspirin, antibiotic…etc.) 
3) Systolic blood pressure ⩽100mmHg or ⩾ 150mmHg, diastolic blood pressure⩽55mmHg or ⩾ 95mmHg 
4) 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 
5) 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
6) Subject who takes alcohol > 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can’t stop drinking during the clinical trials
7) Subject who smokes> 10 cigarettes/day or can’t stop smoking during the clinical trials
8) Taking medication involved in other clinical trials within 90 days before the first administration 
9) Whole blood donation within 60 days or component blood donation within 30 days before the first administration 
10) Taking metabolizing enzyme inducers or inhibitors such as barbitals within 30 days before the first administration 
11) Taking Prescription drug (ETC) or oriental medicine within two weeks and any OTC within 2 weeks before the first administration 
12) Subject with mental illness or substance abuse 
13) Genetic muscle disease, or family history, or history of drug-induced rheumatoid arthritis.
14) Consumption of food which can significantly change the absorption, distribution, metabolism and excretion of a drug within 7 days before the first administration (such as grapefruit or its components) 
15) Those who do not agree with the approved method of contraception during the clinical trial
16) Patients judged as inadequate and clinical trials to test self-determined target for any reason.

Varenicline AUCt, Cmax

0h (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96h

Varenicline tmax

0h (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96h

Varenicline t1/2

0h (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96h

Varenicline AUC∞

0h (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96h