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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004459
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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