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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male
• Intervention / Treatment: Drug: BK-C-0701 480mg; Drug: BK-C-0701 320mg; Drug: Thiocacid HR Tab 600mg

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3; BK-C-0701 480mg	Drug: BK-C-0701 480mg; 480mg for 1 day
EXPERIMENTAL: 2; BK-C-0701 320mg	Drug: BK-C-0701 320mg; 320mg for 1 day
ACTIVE_COMPARATOR: 1; Thioctacid HR tab 600mg	Drug: Thiocacid HR Tab 600mg; 600mg for 1 day

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: August 1, 2009

Study Registration Dates

• First Submitted: December 10, 2010
• First Submitted That Met QC Criteria: December 10, 2010
• First Posted (ESTIMATE): December 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 13, 2010
• Last Update Submitted That Met QC Criteria: December 10, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: BK-C-0701-101