Unique ID issued by UMIN | UMIN000009976 |
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Receipt number | R000011686 |
Scientific Title | Pharmacokinetics of salazosulfapiridine with crucumin and blood miRNA-328 |
Date of disclosure of the study information | 2013/02/22 |
Last modified on | 2014/10/14 15:24:35 |
Pharmacokinetics of salazosulfapiridine with crucumin and blood miRNA-328
Pharmacokinetics of salazosulfapiridine with crucumin
Pharmacokinetics of salazosulfapiridine with crucumin and blood miRNA-328
Pharmacokinetics of salazosulfapiridine with crucumin
Japan |
healthy male and female
Adult |
Others
YES
1) to evaluate blood miRNA levels as biomarker for BCRP function
2) to assess the relationship between change in miR-328 expression and BCRP function
Pharmacokinetics
pharmacokinetics of salazosulfapiridine, blood miR-328 levels
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Food |
salazosulfapiridine, wash out, crucumin, salazosulfapiridine
20 | years-old | <= |
45 | years-old | >= |
Male and Female
The investigators must ensure that all subjects being considered meet the ollowing
inclusion criteria:
1) Japanese healthy male or female who is capable to understand and sign the informed consent
2) 20-45 years of age
3) BMI 17.6-26.4
4) good health as determined by physical examination, vital signs and laboratory tests.
The investigators must ensure that all subjects being considered meet the ollowing
exclusion criteria or conditions:
1) history of allergy to any drugs
2) medical attention within 2 months prior to participation
3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
4) donation of 400 mL or more of blood within 12 weeks prior to participation
5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity
6) history of drug abuse
7) alcohol abuse.
45
1st name | |
Middle name | |
Last name | Shin Irie |
LTA
Sugioka Memorial Hospital
3-6-1, Kashiiteruha, Higashi-ku, Fukuoka
092-662-3608
shin-irie@lta-med.com
1st name | |
Middle name | |
Last name | Noritomo Izumi |
LTA
Hakata Clinic
Random Square 5 - 7 FL, 6-18, Tenyamachi, Hakata-ku, Fukuoka
092-283-7701
noritomo-izumi@lta-med.com
Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University
Japanese Society for the Promotion of Science
NO
2013 | Year | 02 | Month | 22 | Day |
Unpublished
Completed
2013 | Year | 02 | Month | 15 | Day |
2013 | Year | 02 | Month | 22 | Day |
2013 | Year | 02 | Month | 06 | Day |
2014 | Year | 10 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011686
Research Plan | |
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Research case data | |
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