UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006067 |
|---|---|
| Receipt number | 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 12:39:32 |
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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
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
takeutik@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007180
