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

NCT03362008 | Completed Phase 1

• 1 other identifier: JLP-1607-101-PK
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Smoking, Cigarette

Outcome Measures

Primary Outcomes (2)

• AUCt of Varenicline

  96 hours

• Cmax of Varenicline

  96 hours

Study Arms (2)

Group I

EXPERIMENTAL

Period I: administration of Zeropix Period II: administration of Champix®

Drug: Zeropix; Drug: Champix®

Group II

EXPERIMENTAL

Period I: administration of Champix® Period II: administration of Zeropix

Drug: Zeropix; Drug: Champix®

Interventions

Zeropix DRUG

administration of Zeropix

Group I; Group II

Champix® DRUG

administration of Champix®

Group I; Group II

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: July 6, 2017
• Primary Completion: July 26, 2017
• Study Completion: September 8, 2017
• Last Updated: December 5, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)