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

Healthy Adult Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258699
• Other study ID #: BK-C-0701-101
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2010
• Last updated: December 10, 2010
• Start date: August 2009

Study information

• Verified date: December 2010
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Adult Male

Intervention

Drug:
• Thiocacid HR Tab 600mg
600mg for 1 day
• BK-C-0701 320mg
320mg for 1 day
• BK-C-0701 480mg
480mg for 1 day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of,