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

Bukwang Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: BK-C-0701 480mg; Drug: Thiocacid HR Tab 600mg; Drug: BK-C-0701 320mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01258699

BK-C-0701-101

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

3

Experimental group

Description:

BK-C-0701 480mg

Treatment:

Drug: BK-C-0701 480mg

2

Experimental group

Description:

BK-C-0701 320mg

Treatment:

Drug: BK-C-0701 320mg

1

Active Comparator group

Description:

Thioctacid HR tab 600mg

Treatment:

Drug: Thiocacid HR Tab 600mg