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:
Bukwang Pharmaceutical
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
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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
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 May 22, 2013