Study of Evaluation of Cavir Tab. 0.5mg With Food Effect on Pharmacokinetics and Safety

Study Overview
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Brief Summary
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In this clinical trial, the investigator will clarify the difference in pharmacokinetics between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high fatty meal for healthy adult volunteer. The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.

Official Title
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A Randomized, Open-label, 3-way Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics and Safety of Single-dose Cavir Tab. 0.5mg With Baraclude Tab. 0.5mg in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Baraclude Tab. 0.5mg, fasting
* Drug: Cavir Tab. 0.5mg, fasting
* Drug: Cavir Tab. 0.5mg, high fatty meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male, aged 19   45 at screening date Subject's weight is in range from -120 percentage to +120 percentage of ideal body weight which is calculated by { height (cm) - 100} * 0.9. The Subject is willing and able to provide written informed consent to participate in the study Exclusion Criteria: Subject has a history of clinically significant disease. Subject has a digestive disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc) or abdomen surgery (exclude, simple appendectomy or hernia operation). Subject has a hypersensitivity history which is clinically significance or additives. Subject is inappropriate to screening (disease history, physical examination, vital sings, electrocardiogram, laboratory test etc.) Subject has a laboratory test result as indicated by and one of the following. serum aspartate aminotransferase> 1.25 * normal limit serum Total bilirubin > 1.5 * normal upper limit serum CPK > 1.5 * normal upper limit eGFR(estimated Glomerular Filtration Rate) calaulated by MDRD (Modification of Diet in Renal Disease) formula < 60 mL/min/1.73m2 Subject is hypertension(SBP>140mmHg or DBP>90mmHg) or hypotension(SBP<90mmHg, DBP<60mmHg) Subject has a drug abusing history. Subject is currently abusing alcohol (more than 210 g/week), caffeine(more than 5cups/day) or smoking(more than half pack).

Ages Eligible for Study
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Minimum Age: 19 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baraclude Tab. 0.5mg, fasting<br>Single dose Baraclude Tab. 0.5mg, fasting state | Drug: Baraclude Tab. 0.5mg, fasting<br>* After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)<br>|
| Experimental: Cavir Tab. 0.5mg, fasting<br>Single dose Cavir Tab. 0.5mg, fasting state | Drug: Cavir Tab. 0.5mg, fasting<br>* After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)<br>|
| Experimental: Cavir Tab. 0.5mg, high fatty meal<br>Single dose Cavir Tab. 0.5mg, high fatty meal | Drug: Cavir Tab. 0.5mg, high fatty meal<br>* After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of Entecavir. | phamacokinetic parameter | Within 6 Months After Final Visit of Subject | 
| Area under the plasma concentration versus time curve, last (AUClast) of entecavir. | phamacokinetic parameter | Within 6 Months After Final Visit of Subject. | 
| Number of participants with adverse events. |  | Within 6 Months After Final Visit of Subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir. | Pharmacokinetic parameter | Within 6 Months After Final Visit of Subject. | 
| The time at which the Cmax is observed (Tmax) of entecavir. | Pharmacokinetic parameter, Cmax is the peak plasma concentration. | Within 6 Months After Final Visit of Subject. | 
| Terminal half-life (T1/2) of entecavir. | Pharmacokinetic parameter | Within 6 Months After Final Visit of Subject. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Entecavir, Food effect, Cavir Tab 0.5mg, Baraclude Tab. 0.5mg