UMIN-CTR Clinical Trial

Basic information
Public title	Influence of green tea ingestion on the pharmacokinetics of lisinopril in healthy volunteers
Acronym	Green tea-lisinopril study
Scientific Title	Influence of green tea ingestion on the pharmacokinetics of lisinopril in healthy volunteers
Scientific Title:Acronym	Green tea-lisinopril study
Region	Japan

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

Objectives
Narrative objectives1	Difference in pharmacokinetic parameters of lisinopril by ingestion of green tea catechins
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Area under the plasma concentration-time curve (AUC) of lisinopril
Key secondary outcomes	Urinary excretion of lisinopril

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Food
Interventions/Control_1	Subjects receive an oral dose of lisinopril (Zestril 10mg tablet, Astrazeneca) with 200 ml of water after overnight fasting. Blood sampling and measurements of pulse rate and blood pressure are performed before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours after lininopril administration. Urine collection is performed over 24 hours after the administration. Subjects have a snack and a lunch at 1 and 4 hours, respectively, after the administration.
Interventions/Control_2	Subjects receive an oral dose of lisinopril (Zestril 10mg tablet, Astrazeneca) with 200 ml of water dissolving a green tea extract (epigallocatechin gallate dose: 300 mg) after overnight fasting. Blood sampling and measurements of pulse rate and blood pressure are performed before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours after lininopril administration. Urine collection is performed over 24 hours after the administration. Subjects have a snack and a lunch at 1 and 4 hours, respectively, after the administration.
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	To be healthy without receiving medicines regularly
Key exclusion criteria	Smoker
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yayoi Kameoka
Organization	Fukushima Medical University
Division name	Center for Medical Education and Career Development
Zip code
Address	1 Hikarigaoka, Fukushima 9601295, Japan
TEL	024-547-1156
Email	yayois@fmu.ac.jp

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 9601295, Japan
TEL	024-547-1156
Homepage URL
Email	misaka@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Nakatomi 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	2018 Year 01 Month 20 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	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 15 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	2018 Year 01 Month 19 Day
Last modified on	2018 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035276

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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