UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004459 |
|---|---|
| Receipt number | R000005342 |
| Scientific Title | Effect of pomegranate juice on the pharmacokinetics of midazolam in healthy volunteers. |
| Date of disclosure of the study information | 2010/10/29 |
| Last modified on | 2012/01/30 12:43:40 |
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Basic information
Public title
Effect of pomegranate juice on the pharmacokinetics of midazolam in healthy volunteers.
Acronym
Pomegranate juice - midazolam interaction study
Scientific Title
Effect of pomegranate juice on the pharmacokinetics of midazolam in healthy volunteers.
Scientific Title:Acronym
Pomegranate juice - midazolam interaction study
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of repeated consumption of pomegranate juice on the pharmacokinetic interaction with midazolam.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
pharmacokinetics of midazolam
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
Subjects consume 200 mL of pomegranate juice every day for 14 days, and receive midazolam (0.015 mg/kg) on day 14. After more than 1 week wash-out periods, the subjects consume 200ml of bottle water every day for 14 days, and receive midazolam (0.015 mg/kg) on day 14.
Interventions/Control_2
Subjects consume 200 mL of bottle water every day for 14 days, and receive midazolam (0.015 mg/kg) on day 14. After more than 1 week wash-out periods, the subjects consume 200ml of pomegranate juice every day for 14 days, and receive midazolam (0.015 mg/kg) on day 14.
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 and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Smoker
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL
Homepage URL
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
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 | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/21497708
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
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 27 | Day |
Last modified on
| 2012 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005342
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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