A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects
NCT ID: NCT01258699
Last Updated: 2010-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3
BK-C-0701 480mg
BK-C-0701 480mg
480mg for 1 day
2
BK-C-0701 320mg
BK-C-0701 320mg
320mg for 1 day
1
Thioctacid HR tab 600mg
Thiocacid HR Tab 600mg
600mg for 1 day
Interventions
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Thiocacid HR Tab 600mg
600mg for 1 day
BK-C-0701 320mg
320mg for 1 day
BK-C-0701 480mg
480mg for 1 day
Eligibility Criteria
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Inclusion Criteria
* 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-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.
20 Years
45 Years
MALE
Yes
Sponsors
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Bukwang Pharmaceutical
INDUSTRY
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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BK-C-0701-101
Identifier Type: -
Identifier Source: org_study_id