UMIN-CTR Clinical Trial

Basic information
Public title	Time-dependent effects of green tea on pharmacokinetics of nadolol in healthy volunteers
Acronym	Green tea-nadolol interaction study 2
Scientific Title	Time-dependent effects of green tea on pharmacokinetics of nadolol in healthy volunteers
Scientific Title:Acronym	Green tea-nadolol interaction study 2
Region	Japan

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

Objectives
Narrative objectives1	To investigate time-dependent effects of green tea on phamacokinetics of nadolol in healthy 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	In the first phase, group 1 subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of water. In the second phase, the subjects receive nadolol orally with brewed green tea (150 mL) one hour after taking 150 mL of water. In the third phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of brewed green tea. Oral dose of nadolol is 30 mg. The wash-out period between phases is at least one week.
Interventions/Control_2	In the first phase, group 2 subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of water. In the second phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of brewed green tea. In the third phase, the subjects receive nadolol orally with brewed green tea (150 mL) one hour after taking 150 mL of water. Oral dose of nadolol is 30 mg. The wash-out period between phases is at least one week.
Interventions/Control_3	In the first phase, group 3 subjects receive nadolol orally with brewed green tea (150 mL) one hour after taking 150 mL of water. In the second phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of water. n the third phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of brewed green tea. Oral dose of nadolol is 30 mg. The wash-out period between phases is at least one week.
Interventions/Control_4	In the first phase, group 4 subjects receive nadolol orally with brewed green tea (150 mL) one hour after taking 150 mL of water. In the second phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of brewed green tea. In the third phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of water. Oral dose of nadolol is 30 mg. The wash-out period between phases is at least one week.
Interventions/Control_5	In the first phase, group 5 subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of brewed green tea. In the second phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of water. In the third phase, the subjects receive nadolol orally with brewed green tea (150 mL) one hour after taking 150 mL of water. Oral dose of nadolol is 30 mg. The wash-out period between phases is at least one week.
Interventions/Control_6	In the first phase, group 6 subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of brewed green tea. In the second phase, the subjects receive nadolol orally with brewed green tea (150 mL) one hour after taking 150 mL of water. In the third phase, the subjects receive nadolol orally with water (150 mL) one hour after taking 150 mL of water. Oral dose of nadolol is 30 mg. The wash-out 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 adults
Key exclusion criteria	Smoker
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Junko Middle name Last name Kimura
Organization	Fukushima Medical University, School of Medicine
Division name	Department of Phamacology
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima, 9601295 Japan
TEL	024-547-1156
Email	jkimura@fmu.ac.jp

Public contact
Name of contact person	1st name Shingen Middle name Last name Misaka
Organization	Fukushima Medical University, School of Medicine
Division name	Department of Phamacology
Zip code	960-1295
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	Fukushima Medical University
Address	1 Hikarigaokai, Fukushima
Tel	024-547-1111
Email	rs@fmu.ac.jp

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 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1111/bcp.14315
Number of participants that the trial has enrolled	11
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	2015 Year 08 Month 31 Day
Date of IRB	2015 Year 08 Month 31 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2017 Year 08 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 19 Day
Last modified on	2020 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022436