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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006067
Receipt No. R000007180
Scientific Title Pharmacokinetic interaction between high dose catechin-contained green tea and midazolam
Date of disclosure of the study information 2011/08/01
Last modified on 2012/01/30

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Basic information
Public title Pharmacokinetic interaction between high dose catechin-contained green tea and midazolam
Acronym Green tea-midazolam interaction study
Scientific Title Pharmacokinetic interaction between high dose catechin-contained green tea and midazolam
Scientific Title:Acronym Green tea-midazolam interaction study
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of high catechin-contained green tea on the pharmacokinetics of midazolam
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Pharmacokinetics of midazolam and 1'-hydroxy midazolam
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
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 700 mL of high catechin-contained green tea every day for 13 days. On day 14, subjects are administered midazolam (5 microg/kg) intravenously just after green tea intake. On day 15, subjects take midazolam (15 microg/kg) orally with green tea. After 14 days wash-out periods,
the subjects consume 700 mL of water every day for 13 days. On day 14, subjects are administered midazolam (5 microg/kg) intravenously just after water intake. On day 15, subjects take midazolam (15 microg/kg) orally with water.
Interventions/Control_2 Subjects consume 700 mL of water every day for 13 days. On day 14, subjects are administered midazolam (5 microg/kg) intravenously just after water intake. On day 15, subjects take midazolam (15 microg/kg) orally with water. After 14 days wash-out periods, the subjects consume 700 mL of high catechin-contained green tea every day for 13 days. On day 14, subjects are administered midazolam (5 microg/kg) intravenously just after green tea intake. On day 15, subjects take midazolam (15 microg/kg) orally with green tea.
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 adults
Key exclusion criteria Smoker
Target sample size 15

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 Therapeutics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Takeuchi
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2385
Homepage URL
Email takeutik@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization University of Shizuoka
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 浜松医科大学探索的臨床研究施設

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 01 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 Terminated
Date of protocol fixation
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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
2011 Year 07 Month 29 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=R000007180

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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