Healthy Adult Male
Conditions
Brief summary
This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects.
Interventions
DRUGThiocacid HR Tab 600mg
600mg for 1 day
DRUGBK-C-0701 320mg
320mg for 1 day
DRUGBK-C-0701 480mg
480mg for 1 day
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Countries
South Korea
Outcome results
None listed