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

Phase 1

Completed

• Conditions: Healthy Adult Male
• Interventions: Drug: BK-C-0701 480mg; Drug: BK-C-0701 320mg; Drug: Thiocacid HR Tab 600mg

• Registration Number: NCT01258699
• Lead Sponsor: Bukwang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-12
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Last Update Submitted: 2010-12-10
• Study First Posted: 2010-12-13
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	BK-C-0701 480mg	BK-C-0701 480mg
2	BK-C-0701 320mg	BK-C-0701 320mg
1	Thiocacid HR Tab 600mg	Thioctacid HR tab 600mg

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of