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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03362008

Enrollment

Registered

2017-12-05

Start date

2017-07-06

Completion date

2017-09-08

Last updated

2017-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Cigarette

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® tablet 1 mg in healthy adult male subjects

Interventions

DRUGZeropix

administration of Zeropix

DRUGChampix®

administration of Champix®

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
AUCt of Varenicline	96 hours
Cmax of Varenicline	96 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026