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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002751
Receipt No. R000003336
Scientific Title The pharnmacokinetic and pharmacodynamic interactions between high dose catechin-contained green tea and simvastatin
Date of disclosure of the study information 2009/11/13
Last modified on 2014/12/09

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Basic information
Public title The pharnmacokinetic and pharmacodynamic interactions between high dose catechin-contained green tea and simvastatin
Acronym Drug interactions between catechin and simvastatin
Scientific Title The pharnmacokinetic and pharmacodynamic interactions between high dose catechin-contained green tea and simvastatin
Scientific Title:Acronym Drug interactions between catechin and simvastatin
Region
Japan

Condition
Condition healthy man
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of high-dose catechin on the pharmacokinetics and pharmacodynamics of simvastatin
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes simvastatin pharmacokinetics
plasma lathosterol concentration
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 700ml of catechin-contained green tea(0.65mg/ml) every day for 14 days, and take simvastatin(10mg) on day 14. After 14 days wash-out periods, the subjects consume 700ml of bottle water every day for 14 days, and take simvastatin(10mg) on day 14.
Interventions/Control_2 Subjects consume 700ml of bottle water every day for 14 days, and take simvastatin(10mg) on day 14. After 14 days wash-out periods, the subjects consume 700ml of catechin-contained green tea(0.65mg/ml) every day for 14 days, and take simvastatin(10mg) 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
Key inclusion criteria healthy man
Key exclusion criteria none
Target sample size 20

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 053-435-2385
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Takeuchi
Organization Hamamatsu University School of Medicine
Division name 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 University of Shizuoka
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
2009 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25312732
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
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2014 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003336

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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