Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers

Detailed Description
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32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered comparator and YHP1903 by cross-over design on day1, 8. Subjects in group 2 will be administered YHP1903 and comparator by cross-over design on day1, 8.

Official Title
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A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: YHP1903
* Drug: Champix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2 Acceptable medical history, physical examination, laboratory tests and EKG, during screening Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug Exclusion Criteria: History of clinically significant disease Sitting blood pressure meeting the following criteria at screening: 140 ≤ systolic blood pressure ≤90 (mmHg) 90 ≤ diastolic blood pressure ≤ 60 (mmHg) Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit or Total bilirubin > 2.0 mg/dl at the time of screening Volunteers considered not eligible for the clinical trial by the investigator Administration of other investigational products within 6 month prior to the first dosing.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group1<br>16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8 | Drug: YHP1903<br>* YHP1903 Tab. 1mg<br>Drug: Champix<br>* Comparator Champix Tab. 1mg<br>|
| Other: Group2<br>16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8 | Drug: YHP1903<br>* YHP1903 Tab. 1mg<br>Drug: Champix<br>* Comparator Champix Tab. 1mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | AUCt of Varenicline | 0-96 hours | 
| Cmax | Cmax of Varenicline | 0-96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | AUCinf of Varenicline | 0-96 hours | 
| Tmax | Tmax of Varenicline | 0-96 hours | 
| t1/2 | t1/2 of Varenicline | 0-96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics