None listed
Conditions
Interventions
Drug : Open-label, Randomized, 2-way Crossover
-Part 1: At 1 period oral administration of Impactamin Power,At 2 period oral administration of Aronamin Gold.
-Part 2: At 1 period oral administration o
Sponsors
Ildong pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male Korean subject age 20 to 45 at the screening visit 2. Subject who is over 50kg and As a result of calculated Ideal Body Weight, subject who is within the range of ±20% 3. Physical examination was performed on the basis of this protocol, a subject who has been determined to be suitable to the subject of clinical trials via the interview. That is, subject who does not have congenital or chronic disease and as a result of medical examination, subject who is no pathological symptoms or findings. 4. After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
Exclusion criteria
Exclusion criteria: 1. Subject who has history or presence of clinically significant disease in liver, pancreas, kidney, nervous system, respiratory system, endocrine system, blood•tumor, mental illness, cardiovascular system and urinary system. 2. As the results of clinical laboratory test included other reasons, subjects who is determined to be unsuitable about participation in clinical trial 3. In laboratory tests, the subject who shows the results that fall into any of the following -Aspartate Aminotransferase or Alanine Aminotransferase > above 1.5times of normal range -Total bilirubin > above 1.5times of normal range 4. Subject who takes investigational product of other clinical study within 60 days before the frist administration. 5. Subject who takes whole blood donation within 60 days or apheresis within 20 days before the first administration 6. Subject who is unable takes grapefruit or the fruit product during the clinical trial 7. Subject who takes some ethical drug or herbal medicine within 14 days or some Over The Counter within 7 days before the first administration (Based on the investigator's judgment, if other conditions are appropriate, it is possible to participate in clinical trials) 8. Subject who drinks consistently (above 21 units/week, 1unit=10g of pure alcohol) and can't stop drinking during the treatment period 9. Subject who smokes consistently (above 10cigarettes/day)and can't stop smoking during the treatment period 10. Subject who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 11. Subject who has medical history of use of durgs of abuse 12. Subjects who is determined to be unsuitable about participation in clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, Tmax , AUClast, AUCinf, t1/2 of Total thiamine | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactYim Seok
The Catholic University of Korea
Outcome results
None listed