Healthy Adult
Conditions
Interventions
Oral microdosing of enteric coated of simvastatin
Oral microdosing of non-enteric coated of simvastatin
Oral microdosing of enteric coated of erythromycin
Oral microdosing of non-enteric coated of ery
Sponsors
Oita university hospital, Clinical pharmacology center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male volunteers who are 20~40 years old 2) BMI 18.0-30.0
Exclusion criteria
Exclusion criteria: 1)person who has present and/or past history of disease of heart and circulatory system, liver,kidney and uretary system, and digestive system. 2)person who has drug adiction and/or allergy 3)person who takes drugs which has an effect on the result of this study 4)person who is thoght by medical doctor as unsuitable in physical examinations and blood and biochemistry examinations. 5)person who takes drugs and/or health food product like St.John's wort within 7 days before taking study drugs 6)person who juice wfruit within 7 days before taking study drugs including grapefruitjuice 7)person who usually take health food product like St.John's wort 8)person who joined other clinical study within 3 months before this study and is thougt as unsuitable by medical doctor 9)person who donated blood of 200mL within one month and within 3 months before this study 10)person who is positive HBV,HCV,HIV and syphilis 11)person who has allergy of drug and/or food 12)person who addict drugs and alcohol 12)person who is diagonosed by medical doctors as unsuitable for joinining this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each Cmax,Tmax,AUC 0-T,ACUinf, and of T1/2 of erythromycin and simvastatin | — |
Countries
Japan
Contacts
Public ContactTAKUYA MORIMOTO
Oita university hospital Clinical pharmacology center
Outcome results
None listed