Unique ID issued by UMIN | UMIN000004844 |
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Receipt number | R000005768 |
Scientific Title | Microdosing cinical studies -Assessment of enteric coated drugs |
Date of disclosure of the study information | 2011/01/08 |
Last modified on | 2011/04/10 20:56:41 |
Microdosing cinical studies -Assessment of enteric coated drugs
Microdosing cinical studies -Assessment of enteric coated drugs
Microdosing cinical studies -Assessment of enteric coated drugs
Microdosing cinical studies -Assessment of enteric coated drugs
Japan |
Healthy Adult
Adult |
Others
NO
Purposes of this project are to investigate the Miclodosing (MD) clinical study to detect the difference of enteric coated drugs and non- enteric coated drugs
Bio-availability
Exploratory
Explanatory
Not applicable
Each Cmax,Tmax,AUC 0-T,ACUinf,
and of T1/2 of erythromycin and simvastatin
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
4
Diagnosis
Medicine |
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 erythromycin
20 | years-old | <= |
40 | years-old | >= |
Male
1) Healthy male volunteers who are 20~40 years old
2) BMI 18.0-30.0
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
16
1st name | |
Middle name | |
Last name | TAKUYA MORIMOTO |
Oita university hospital
Clinical pharmacology center
1-1 Hasama Idaigaoka, Yufu city, Oita prefecture, JAPAN
1st name | |
Middle name | |
Last name | TAKUYA MORIMOTO |
Oita university hospital
Clinical pharmacology center
1-1 Hasama Idaigaoka, Yufu city, Oita prefecture, Japan
Oita university hospital, Clinical pharmacology center
Association for promoting drug development
Other
NO
2011 | Year | 01 | Month | 08 | Day |
Unpublished
Completed
2010 | Year | 11 | Month | 14 | Day |
2011 | Year | 01 | Month | 01 | Day |
2011 | Year | 01 | Month | 08 | Day |
2011 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005768
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