A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects

Study Overview
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Brief Summary
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This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects.

Official Title
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A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects

Conditions
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Healthy Adult Male

Intervention / Treatment
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* Drug: Thiocacid HR Tab 600mg
* Drug: BK-C-0701 320mg
* Drug: BK-C-0701 480mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male is between 20 and 45 Weight is between 50 and 90kg, and in 20% of ideal weight. Ideal weight(kg)=(height(cm)-100)*0.9 Medical history, physical examination, ECG and laboratory test are suitable to the study if judged by an investigator. Patient is willing to use an effective method of contraception during the study and for up to 1 months after the use of study drug ceases. (Effective method=spermicide with condom) Subject is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patient received drug affected to the study within 14 days from the study initiation. Patient received drug-metbolizing enzyme inducer or inhibitor such as Barbiturates within 1 month from the study initiation. Subject is hypersensitive investigational drug(Thioctic acid). Patient with gastrointestinal history affected absorbing investigational drug or inhibiting normal gastrointestinal motility, gastrointestinal operation or gastrointestinal wound. Patient with renal, hepatic, bronchopulmonary, cardiovascular, gastrointestinal, metabolic, neurological, psychotic, oncologic, allergic disease, myocardial infarction, cardiac crisis, hepatitis or pancreatitis history. ECG is abnormal. Patient abused drug. Patient joined other clinical study within 3 months from the study initiation. Patient doanted whole blood within 2 months or plasma blood within 1 month from the first medication. HBsAg, HCV Ab or HIV Ab are positive. Patient who was not suitable to the study if judged by an 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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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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3<br>BK-C-0701 480mg | Drug: BK-C-0701 480mg<br>* 480mg for 1 day<br>|
| Experimental: 2<br>BK-C-0701 320mg | Drug: BK-C-0701 320mg<br>* 320mg for 1 day<br>|
| Active Comparator: 1<br>Thioctacid HR tab 600mg | Drug: Thiocacid HR Tab 600mg<br>* 600mg for 1 day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |