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

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01258699
First received: December 10, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy Adult Male
Drug: Thiocacid HR Tab 600mg
Drug: BK-C-0701 320mg
Drug: BK-C-0701 480mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects

Further study details as provided by Bukwang Pharmaceutical:

Estimated Enrollment: 30
Study Start Date: August 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258699

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01258699     History of Changes
Other Study ID Numbers: BK-C-0701-101
Study First Received: December 10, 2010
Last Updated: December 10, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on July 31, 2014