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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019398
Receipt No. R000022436
Scientific Title Time-dependent effects of green tea on pharmacokinetics of nadolol in healthy volunteers
Date of disclosure of the study information 2015/11/01
Last modified on 2020/04/23

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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

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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