UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006064
Receipt number R000007174
Scientific Title Effect of green tea consumption on pharmacokinetics and pharmacodynamics of nadolol in healthy volunteers
Date of disclosure of the study information 2011/08/01
Last modified on 2014/12/09 13:48:06

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Basic information

Public title

Effect of green tea consumption on pharmacokinetics and pharmacodynamics of nadolol in healthy volunteers

Acronym

Green tea - nadolol interaction study

Scientific Title

Effect of green tea consumption on pharmacokinetics and pharmacodynamics of nadolol in healthy volunteers

Scientific Title:Acronym

Green tea - nadolol interaction study

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of chronic consumption of catechin-rich green tea on the
pharmacokinetics and pharmacodynamics of nadolol

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Plasma concentration of nadolol
Urinary excretion of nadolol
Blood pressure and heart rate

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

2

Purpose of intervention

Prevention

Type of intervention

Medicine Food

Interventions/Control_1

Subjects take 700 mL of catechin-rich green tea every day for 14 days, and receive 30 mg of nadolol orally with green tea on day 15.

Interventions/Control_2

Subjects take 700 mL of water every day for 14 days, and receive 30 mg of nadolol with water on day 15.

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

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junko Kimura

Organization

Fukushima Medical University

Division name

Department of Pharmacology

Zip code


Address

1 Hikarigaoka, Fukushima, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shingen Misaka

Organization

Fukushima Medical University

Division name

Department of Pharmacology

Zip code


Address

1 Hikarigaoka, Fukushima, Japan

TEL

024-547-1156

Homepage URL


Email

misaka@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

MEXT

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



Other administrative information

Date of disclosure of the study information

2011 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24419562

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

2011 Year 07 Month 27 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 28 Day

Last modified on

2014 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name