UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004221 |
|---|---|
| Receipt number | 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 19:32:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
misaka@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
