None listed
Conditions
Interventions
Drug : Open-label, Randomized, 2-way Crossover
-Part 1: At 1 period oral administration of VitaB 100 Tablet,At 2 period oral administration of Aronamin Gold.
-Part 2: At 1 period oral administration
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. A person who has acute symptom at screening phase 2. A person who has any disease or symptoms which is clinically significant 3. A person who had been determined as 'not suitable for study' during healthy examination(medical history, physical exam, lab test, Etc) in screening period 4. A person who had some lab data below. -AST or ALT > 1.5 times than normal -Total bilirubin > 1.5 times than normal 5. A person who has a history of clinically significant allergy. 6. A person who has a history of anaphylaxis. 7. A person who has medical history of drug abuse or misuse. 8. A person who had enrolled to other clinical trial within the last 60 days. 9. A person who had donated blood within the last 60 days or who donated substance of blood with in last 20 days. 10. A person who can't take a meal derived from this trial. 11. A person who has taken abnormal meals like which can affect to drug Absorbtion, Distribution, Metabolism, Excretion. 12. A person who can't stop taking grapefuit contained foods. 13. A person who has taken other prescription medicine or oriental drugs within the last 14 days, Or Over the counter drugs within the last 7 days 14. A person who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or who can't stop the caffein since 24hours before hospitalization. 15. A person who has taken alcohol more than 30g/day or someone who can't stop drinking from 24hours before enrollment to discharging from hospital. 16. A person who smoked more than 10 piece of tobacco/day or can't stop smoking from 24hours before enrollment to discharging from hospital. 17. A person who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 18. A person 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 ContactDong Seok Yim
The Catholic University of Korea
Outcome results
None listed