Status:
COMPLETED
A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Healthy Adult Male
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01258699
Start Date
August 1 2009
Last Update
December 13 2010
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea