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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019761
Receipt No. R000022822
Scientific Title Dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy volunteers
Date of disclosure of the study information 2015/12/01
Last modified on 2018/03/01

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Basic information
Public title Dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy volunteers
Acronym GT-nadolol interaction study 3
Scientific Title Dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy volunteers
Scientific Title:Acronym 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
1st name
Middle name
Last name Junko Kimura
Organization Fukushima Medical University, School of Medicine
Division name Department of Phamacology
Zip code
Address 1 Hikarigaoka, Fukushima, 9601295 Japan
TEL 024-547-1156
Email jkimura@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Abe
Organization Fukushima Medical University, School of Medicine
Division name Department of Phamacology
Zip code
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)

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
2015 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29480324
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
2015 Year 10 Month 22 Day
Date of IRB
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

Other
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

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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