A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502

Study Overview
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Brief Summary
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The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT
* Drug: varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between ≥20 and ≤45 years old Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2 Subject who voluntarily agrees to participate in this study and signs the informed consent form. Exclusion Criteria: History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder. With symptoms indicating acute illness within 28 days prior to the first IP administration. Any medical history that may affect drug absorption, distribution, metabolism, and excretion. Any clinically significant activity of chronic medical illness. History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included). Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL. Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration or use of over-the-counter medications (OTC) and vitamin products within 10 days prior to study drug administration. Inability to take standard hospital diet. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days, or blood transfusion within 30 days prior to the first IP administration. Exposure to any investigational drug or placebo within 90 days prior to the last IP administration. Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week). Any use of tobacco or nicotine within three months. Subjects rejected to use clinically effective contraceptive methods during the study period. Subjects having been deemed inappropriate for the trial as determined by the investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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
Interventional Model Description: an open-label, randomized, single-dose crossover clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT<br>period 1: HGP1604 1mg (reference drug, R) will be administered once orally. period 2: HIP1502 1mg (test drug, T) will be administered once orally after 14 days of the washout period. | Drug: varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT<br>* varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.<br>|
| Experimental: TR<br>period 1: HIP1502 1mg (test drug, T) will be administered once orally. period 2: HGP1604 1mg (reference drug, R) will be administered once orally after 14 days of the washout period. | Drug: varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR<br>* varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | area under the plasma concentration-time curve | 0 (predose)   96 hours | 
| Cmax | maximum plasma concentration of the drug | 0 (predose)   96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | time to maximum plasma concentration | 0 (predose)   96 hours | 
| T1/2 | terminal elimination half-life | 0 (predose)   96 hours | 
| CL/F | apparent total body clearance of the drug from plasma | 0 (predose)   96 hours | 
| Vd/F | apparent volume of distribution | 0 (predose)   96 hours |