Unique ID issued by UMIN | UMIN000002715 |
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Receipt number | R000003310 |
Scientific Title | Clinical research for non-linearity of efflux pathway and drug-drug interaction via efflux-type transporter at digestive tract |
Date of disclosure of the study information | 2009/11/05 |
Last modified on | 2009/12/29 11:06:25 |
Clinical research for non-linearity of efflux pathway and drug-drug interaction via efflux-type transporter at digestive tract
sulfasalazine clinical research
Clinical research for non-linearity of efflux pathway and drug-drug interaction via efflux-type transporter at digestive tract
sulfasalazine clinical research
Japan |
health male subjects
Not applicable |
Others
YES
To compare PK profile of 100 microG sulfasalazine with its 2g dose and evaluate curcumin inhibitory effect on BCRP.
Pharmacokinetics
salfasalazine PK profiles
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Food |
sulfasalazine and curcumin
20 | years-old | <= |
35 | years-old | >= |
Male
the investigors must ensure that all subjects being considerd meet the following inclusion
criteria:
1) Japanese healthy male who is capable to
understand and sign the informed consent.
2) 20-35 years of age
3)BMI 18.0-25.0
4)good health as determined by physical
examination, vital signs and laboartory tests etc..
the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions:
1)any impairment of blood, liver and kidney
2)asthma
3)Acute Intermittent Porphyria
4)Glucose-6-phosphate dehydrogenase deficiency
5)any medication and food ingestion containing curcumin within 7 days prior to test drug administration
6)fruit juice ingestion containing grapefruit, orange or apple within 7 days prior to test drug administration
7)dialy user of St. John's wort
8)recent (past 4 months) participation in other clinical trial for investigational new chemical entity
9)donation of 400mL or more of blood within 12 weeks prior to participation, donation of 200mL or more of blood within
4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
10)positive results on HBs-AG, HCV-AB, HIV-AB, TPHA
11)history of allergy to any drugs and foods
12)history of drug or alcohol abuse and incapable of abstinence from smoking and alcohol during protocol designated period
13)excess daily alcohol ingestion
14)inappropriate subject as determined by physical examination, vital signs, laboartory tests and ECG at screening
15)history of sulfasalazine administration (either clinical research or medication)
16)vulnerable for alcohol intake
17)inappropriate subjects as determined by phsicians
8
1st name | |
Middle name | |
Last name | Hidetoshi Furuie |
OPHAC Hospital
OPHAC Hospital
4-1-29 Miyahara Yodogawa-ku Osaka
1st name | |
Middle name | |
Last name | Saiko Yamada |
OPHAC Hospital
pharmacy
saiko.yamada@ophac-h.jp
APDD
APDD
NO
2009 | Year | 11 | Month | 05 | Day |
Unpublished
Completed
2009 | Year | 10 | Month | 26 | Day |
2009 | Year | 11 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2009 | Year | 11 | Month | 05 | Day |
2009 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003310
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