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OpenTrials
Completed

NCT Number: NCT01258699

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thiocacid HR Tab 600mg

Drug

600mg for 1 day

BK-C-0701 320mg

Drug

320mg for 1 day

BK-C-0701 480mg

Drug

480mg for 1 day

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Important dates

Study start
2009
First posted
Dec 13, 2010
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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