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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004221
Receipt No. R000005075
Scientific Title Effects of itraconazole, riphampicin and grapefruit juice on the pharmacokinetics and pharmacodynamics of nadolol in healthy volunteers
Date of disclosure of the study information 2010/10/01
Last modified on 2013/10/08

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Basic information
Public title Effects of itraconazole, riphampicin and grapefruit juice on the pharmacokinetics and pharmacodynamics of nadolol in healthy volunteers
Acronym Nadolol-drug interaction study
Scientific Title Effects of itraconazole, riphampicin and grapefruit juice on the pharmacokinetics and pharmacodynamics of nadolol in healthy volunteers
Scientific Title:Acronym Nadolol-drug interaction study
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of inhibitors or inducers of drug transporters on the pharmacokinetics and pharmacodynamics of nadolol
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Nadolol pharmacokinetics
Blood pressure and heart rate
Key secondary outcomes

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 4
Purpose of intervention Prevention
Type of intervention
Medicine Food
Interventions/Control_1 Subjects receive orally a single dose of nadolol (30 mg) with itraconazole (100 mg) and water.
Interventions/Control_2 Subjects receive orally a single dose of nadolol (30 mg) with grapefruit juice (300 mL).
Interventions/Control_3 Subjects take 450 mg of rifampicin every day for 6 days, and receive orally a single dose of nadolol (30 mg) with water on day 7.
Interventions/Control_4 Subjects receive orally a single dose of nadolol (30 mg) with water.
Interventions/Control_5
Interventions/Control_6
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
Middle name
Last name Junko Kimura
Organization Fukushima Medical University
Division name Department of Pharmacology
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shingen Misaka
Organization Fukushima Medical University
Division name Department of Pharmacology
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1153
Homepage URL
Email misaka@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
Organization
Division
Category of Funding Organization
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
2010 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1002/jcph.95/abstract
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
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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

Management information
Registered date
2010 Year 09 Month 16 Day
Last modified on
2013 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005075

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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