UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004687 |
|---|---|
| Receipt number | R000005577 |
| Scientific Title | Drug-supplement interactions on intestinal absorption and its genetic individual variations |
| Date of disclosure of the study information | 2010/12/10 |
| Last modified on | 2011/06/10 12:26:37 |
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Basic information
Public title
Drug-supplement interactions on intestinal absorption and its genetic individual variations
Acronym
Drug-supplement interactions on intestinal absorption and its genetic individual variations
Scientific Title
Drug-supplement interactions on intestinal absorption and its genetic individual variations
Scientific Title:Acronym
Drug-supplement interactions on intestinal absorption and its genetic individual variations
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
to identify OATP2B1 involvement and inhibitory effect of curcumin in salazosulfapyridine and rosuvastatin oral absorption mechanisms
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PK parameters of salazosulfapyridine and rosuvastatin plasma concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
coadministration of salazosulfapyridine and rosuvastatin without curcumin
Interventions/Control_2
coadministration of salazosulfapyridine and rosuvastatin with curcumin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
the investigors must ensure that all subjects being considerd meet the following inclusion criteria
1) capable to understand and sign the informed consent.
2) 20-45 years of age
3)BMI 17.6-26.4
4)genotype result shows one of the following groups;
A)BCRP wild homo/OATP2B1 wild homo
B)BCRP wild homo/OATP2B1mut/wild
5)good health as determined by physical examination, vital signs ECG and laboartory tests.
Key exclusion criteria
the investigors must ensure that all subjects being considerd meet the following exclusion criteria or conditions
1) blood disorder and impairment of liver and kidney function
2) history of asthma
3) porphyria patient
4) deficiency of glucose-6-phosphdehydrogenase
5) impairment of liver or kidney functions
6) grapefruit, orange and apple juice intake within 7 days prior to test drug administration
7) regular use of St. John's Wort
8) recent (past 4 months) participation in other clinical trial using new chemical entity
9) donation of 400mL or more of blood within 3 months prior to participation, donation of
200mL or more of blood within 1 month prior to participation, or donation of component blood within 2 weeks prior to participation
10) positive serologic reaction of syphilis, positive result of HIV test, HBsAg and HCVAb
11) history of multiple and recurring allergies to medicines or food
12) history of drug or alcohol abuse and capable to refrain from alcohol for the designated term
13) the investigator determines this trial participation inadequate by the information at the screening visit
14) vulnerable to alcohol or incapable to intake alcohol
15) the investigator determines this trial participation inadequate
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sugiyama Yuichi |
Organization
The University of Tokyo, Graduate school of Pharmceutical Sciences
Division name
Department of Molecular Pharmacokinetics
Zip code
Address
7-3-1 Hongo, Bunkyo Tokyo
TEL
03-5841-4770
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
APDD
Division name
APDD
Zip code
Address
TEL
Homepage URL
inaon-heart@bpost.plala.or.jp
Sponsor or person
Institute
APDD
Institute
Department
Personal name
Funding Source
Organization
NEDO
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 08 | Day |
Last modified on
| 2011 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005577
