NCT01258699CompletedPhase 1
A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects
Bukwang Pharmaceutical1 site in 1 country30 target enrollmentStarted: August 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief Summary
This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
3
Experimental
BK-C-0701 480mg
Intervention: BK-C-0701 480mg (Drug)
2
Experimental
BK-C-0701 320mg
Intervention: BK-C-0701 320mg (Drug)
1
Active Comparator
Thioctacid HR tab 600mg
Intervention: Thiocacid HR Tab 600mg (Drug)
Investigators
Study Sites (1)
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