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

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

Study Overview

• Status: Completed
• Conditions: Smoking, Cigarette
• Intervention / Treatment: Drug: Zeropix; Drug: Champix®

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Period I: administration of Zeropix Period II: administration of Champix®	Drug: Zeropix; administration of Zeropix; Drug: Champix®; administration of Champix®
Experimental: Group II; Period I: administration of Champix® Period II: administration of Zeropix	Drug: Zeropix; administration of Zeropix; Drug: Champix®; administration of Champix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCt of Varenicline	96 hours
Cmax of Varenicline	96 hours

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2017
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): September 8, 2017

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: JLP-1607-101-PK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No