UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy volunteers
Title of the study (Brief title)	GT-nadolol interaction study 3
Region	Japan

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

Objectives
Narrative objectives1	To investigate dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy adult volunteers.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood samples are collected before and at 0.5, 1, 2, 3, 4, 6, 8, 24,and 48 hours after nadolol administration. Urine samples are obtained over 48 hours after nadolol administration. Blood pressure and pulse rate are monitored before and at 0.5, 1, 2, 3, 4, 6, 8, 24, and 48 hours after nadolol adoministration.
Key secondary outcomes	Plasma concentrations of nadolol Urinary excretions of nadolol Blood pressure Pulse rate

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	6
Purpose of intervention	Prevention
Type of intervention	Medicine Food
Interventions/Control_1	Subjects in this group receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Interventions/Control_2	Subjects in this group receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Interventions/Control_3	Subjects in this group receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Interventions/Control_4	Subjects in this group receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Interventions/Control_5	Subjects in this group receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Interventions/Control_6	Subjects in this group receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. The washout period between phases is at least one week.
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 volunteers
Key exclusion criteria	Smoker
Target sample size	12

Research contact person
Name of lead principal investigator	Junko Kimura
Organization	Fukushima Medical University, School of Medicine
Division name	Department of Phamacology
Address	1 Hikarigaoka, Fukushima, 9601295 Japan
TEL	024-547-1156
Email	jkimura@fmu.ac.jp

Public contact
Name of contact person	Osamu Abe
Organization	Fukushima Medical University, School of Medicine
Division name	Department of Phamacology
Address	1 Hikarigaoka, Fukushima, 9601295 Japan
TEL	024-547-1156
Homepage URL
Email	osamu-a@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)

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 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 22 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29480324
Results
Other related information	Intervention No.11 to No.24 can be predicted by intervention from No.1 to No.10

Management information
Registered date	2015 Year 11 Month 12 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022822