UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019398
Receipt number 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 14:40:07

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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 or person

Institute

Fukushima Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022436