A Clinical Trial to Compare Pharmacokinetics of the CDFF0318 and Champix Tab. 1mg

Study Overview
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Brief Summary
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A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the CDFF0318 and Champix Tab. 1mg (Varenicline tartrate) in Healthy Male Volunteers

Official Title
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A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the CDFF0318 and Champix Tab. 1mg (Varenicline Tartrate) in Healthy Male Volunteers

Conditions
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Smoking Cessation, Pharmacokinetics

Intervention / Treatment
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* Drug: CDFF0318, Champix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects aged 19 to 45 years a body mass index of 18.0-30.0 kg/m2 Exclusion Criteria: Subjects with disease history or current disease of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, urinary system, cardiovascular system, etc. Subjects with a history of gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of investigational drugs Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing varenicline and other drugs (ketoprofen, aspirin, antibiotics, etc.) Subjects who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug, or who eat food that may affect drug metabolism

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Experimental: Sequence A(RT)<br>Reference drug (Champix) -> washout -> test drug (CDFF0318) | Drug: CDFF0318, Champix<br>* CDFF0318: Varenicline salt changed Champix: Varenicline tartrate<br>|
| Experimental: Sequence B(TR)<br>Test drug (CDFF0318) -> washout -> reference drug (Champix) | Drug: CDFF0318, Champix<br>* CDFF0318: Varenicline salt changed Champix: Varenicline tartrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUC0-t) | AUC0-t of CDFF0318 and Champix Tab. 1mg | 72 hours | 
| Pharmacokinetics (Cmax) | Cmax of CDFF0318 and Champix Tab. 1mg | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (Vital sign) | Blood pressure (mmHg) | 72 hours | 
| Safety and tolerability (Vital sign) | Heart rate (beats/min) | 72 hours | 
| Safety and tolerability (12-lead ECG) | ventricular rate (beats/min) | 72 hours | 
| Safety and tolerability (12-lead ECG) | PR interval (msec) | 72 hours | 
| Safety and tolerability (Laboratory tests) | Creatinine [mg/dL] | 72 hours | 
| Safety and tolerability (Laboratory tests) | AST, ALT [IU/L] | 72 hours | 
| Safety and tolerability (Laboratory tests) | eGFR [mL/min/1.73m^2] | 72 hours | 
| Safety and tolerability (Adverse events) | Adverse events were collected regardless of the time point when the subject complained of symptoms. Adverse events were assessed by CTCAE v5.0 | 72 hours |