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
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 April 15, 2014