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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362008
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jeil Pharmaceutical Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Smoking, Cigarette Drug: Zeropix Drug: Champix® Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 6, 2017
Actual Primary Completion Date : July 26, 2017
Actual Study Completion Date : September 8, 2017

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Arms and Interventions
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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®


Outcome Measures
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Primary Outcome Measures :
  1. AUCt of Varenicline [ Time Frame: 96 hours ]
  2. Cmax of Varenicline [ Time Frame: 96 hours ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362008


Locations
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Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03362008    
Other Study ID Numbers: JLP-1607-101-PK
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs