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

NCT01258699 | Completed Phase 1

• 1 other identifier: BK-C-0701-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Male

Study Arms (3)

3

EXPERIMENTAL

BK-C-0701 480mg

Drug: BK-C-0701 480mg

2

EXPERIMENTAL

BK-C-0701 320mg

Drug: BK-C-0701 320mg

1

ACTIVE COMPARATOR

Thioctacid HR tab 600mg

Drug: Thiocacid HR Tab 600mg

Interventions

Thiocacid HR Tab 600mg DRUG

600mg for 1 day

1

BK-C-0701 320mg DRUG

320mg for 1 day

2

BK-C-0701 480mg DRUG

480mg for 1 day

3

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: August 1, 2009
• Last Updated: December 13, 2010

Record last verified: 2010-12

Locations

KR (1)