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

Smoking, Cigarette Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362008
• Other study ID #: JLP-1607-101-PK
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2017
• Last updated: November 29, 2017
• Start date: July 6, 2017
• Est. completion date: September 8, 2017

Study information

• Verified date: November 2017
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 8, 2017
• Est. primary completion date: July 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking, Cigarette

Intervention

Drug:
• Zeropix
administration of Zeropix
• Champix®
administration of Champix®

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of Varenicline		96 hours
Primary	Cmax of Varenicline		96 hours