UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020286 |
|---|---|
| Receipt number | R000023423 |
| Scientific Title | Evaluation of drug interactions of cytochrome P450 by single-substrate administrations and the cocktail method |
| Date of disclosure of the study information | 2015/12/21 |
| Last modified on | 2016/12/20 09:28:35 |
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Basic information
Public title
Evaluation of drug interactions of cytochrome P450 by single-substrate administrations and the cocktail method
Acronym
Evaluation of drug interactions of cytochrome P450 by single-substrate administrations and the cocktail method
Scientific Title
Evaluation of drug interactions of cytochrome P450 by single-substrate administrations and the cocktail method
Scientific Title:Acronym
Evaluation of drug interactions of cytochrome P450 by single-substrate administrations and the cocktail method
Region
| Japan |
Condition
Condition
drug interaction
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the changes of cytochrome P450
(CYP) activities (1A2, 2C9, 2C19, 2D6) evaluated between single-probe administrations and cocktail method after administrations of a CYP-inducer and CYP inhibitors.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics of caffeine, losartan omeprazole, dextromethorphan
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
drugs(CYP inducer and inhibitor)
inducer : rifampicin 450 mg s.i.d for 6 days before trial
inhibitor : cimetidine 400mg b.i.d for 2 days before trial, fluvoxamine 25 mg b.i.d for 2days before trial
Interventions/Control_2
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
| Not applicable |
Gender
Male
Key inclusion criteria
1 helthy male, over 20 years old
2 without hepatic disorder, renal disorder and disease under treatment
3 without medication allergy and idiosyncrasy
4 without drug dependence and alchol dependence
5 with consent to take part in this study by document
Key exclusion criteria
1 being unwellness
2 with abnormalities of bllod examination in advance
3 inadequateness to this study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapetics
Zip code
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Hakamata |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapetics
Zip code
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
Homepage URL
hakamata@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Sports, Science, and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Parmacy Practice and Science, School of PharmaceuticalaScience, University of Shizuoka
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
| 2015 | Year | 12 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 21 | Day |
Last modified on
| 2016 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023423
