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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016339
Receipt No. R000018920
Scientific Title Effect of green tea ingestion on pharmacokinetics of fluvastatin in healthy volunteers
Date of disclosure of the study information 2015/02/01
Last modified on 2018/02/19

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Basic information
Public title Effect of green tea ingestion on pharmacokinetics of fluvastatin in healthy volunteers
Acronym Green tea-fluvastatin interaction study
Scientific Title Effect of green tea ingestion on pharmacokinetics of fluvastatin in healthy volunteers
Scientific Title:Acronym Green tea-fluvastatin interaction study
Region
Japan

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

Objectives
Narrative objectives1 To assess the effects of brewed green tea and green tea extract on pharmacokinetics of fluvastatin
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Plasma concentrations of fluvastatin
Urinary excretion of fluvastatin
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine Food
Interventions/Control_1 Subjects receive 20 mg of fluvastatin orally with 300 mL of brewed green tea after overnight fasting. Blood samples are collected before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after fluvastatin administration. Urine samples are obtained over 24 hours after fluvastatin administration.
Interventions/Control_2 Subjects receive 20 mg of fluvastatin orally with 300 mL of water and a green tea extract after overnight fasting. Blood samples are collected before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after fluvastatin administration. Urine samples are obtained over 24 hours after fluvastatin administration.
Interventions/Control_3 Subjects receive 20 mg of fluvastatin orally with 300 mL of water after overnight fasting. Blood samples are collected before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after fluvastatin administration. Urine samples are obtained over 24 hours after fluvastatin administration.
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 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junko Kimura
Organization Fukushima Medical University, School of Medicine
Division name Department of Pharmacology
Zip code
Address 1 Hikarigaoka, Fukushima, 9601295 Japan
TEL 024-547-1153
Email jkimura@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingen Misaka
Organization Fukushima Medical University, School of Medicine
Division name Department of Pharmacology
Zip code
Address 1 Hikarigaoka, Fukushima, 9601295 Japan
TEL 024-547-1156
Homepage URL
Email misaka@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Honjo International Scholarship Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs00228-018-2420-x
Number of participants that the trial has enrolled
Results
Single concomitant administration of green tea is unlikely to affect the pharmacokinetics of fluvastatin in healthy volunteers. 
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
2015 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 02 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
2015 Year 01 Month 26 Day
Last modified on
2018 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018920

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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