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

NCT ID: NCT03362008

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2017-09-08

Brief Summary

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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

Detailed Description

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Conditions

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Smoking, Cigarette

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

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

Group Type EXPERIMENTAL

Zeropix

Intervention Type DRUG

administration of Zeropix

Champix®

Intervention Type DRUG

administration of Champix®

Group II

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

Group Type EXPERIMENTAL

Zeropix

Intervention Type DRUG

administration of Zeropix

Champix®

Intervention Type DRUG

administration of Champix®

Interventions

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Zeropix

administration of Zeropix

Intervention Type DRUG

Champix®

administration of Champix®

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inha University Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JLP-1607-101-PK

Identifier Type: -

Identifier Source: org_study_id