UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005891 |
|---|---|
| Receipt number | R000006957 |
| Scientific Title | The effect of apple juice on the pharmacokinetics and pharmacodynamics of celiprolol. |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2015/01/07 14:32:22 |
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Basic information
Public title
The effect of apple juice on the pharmacokinetics and pharmacodynamics of celiprolol.
Acronym
The effect of apple juice on the pharmacokinetics and pharmacodynamics of celiprolol.
Scientific Title
The effect of apple juice on the pharmacokinetics and pharmacodynamics of celiprolol.
Scientific Title:Acronym
The effect of apple juice on the pharmacokinetics and pharmacodynamics of celiprolol.
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify whether the PK and PD of celiprolol are influenced by taking apple juice via inhibiting transporters or not.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacokinetics of celiprolol
blood pressure
pulse rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
oral administration of celiprolol and apple juice
Interventions/Control_2
oral administration of celiprolol and water
Interventions/Control_3
Interventions/Control_4
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
BMI: 17kg/m2<, <28kg/m2
capable of understanding and adhering to the protocol
capable of anticonception during the trial
Key exclusion criteria
having acute or chronic disease
liver dysfunction
renal dysfunction
electrolyte abnormality
ECG abnormality
hyper- or hypo-tention
drug dependence
drug allergy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Imai |
Organization
Oita University Faculty of Medicine
Division name
Dept of clinical pharmacology and therapeutics
Zip code
Address
1-1 Idaigaoka Hasama Yufu-city, Oita, JAPAN
TEL
097-586-5952
imaih@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Imai |
Organization
Oita University Faculty of Medicine
Division name
Dept of clinical pharmacology and therapeutics
Zip code
Address
1-1 Idaigaoka Hasama Yufu-city, Oita, JAPAN
TEL
097-586-5952
Homepage URL
imaih@oita-u.ac.jp
Sponsor or person
Institute
Oita University, Faculty of medicine
Dept of clin pharmacol & ther
Institute
Department
Personal name
Funding Source
Organization
research grant for scientific research of MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
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
| 2011 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
| 2011 | Year | 06 | Month | 30 | Day |
Last modified on
| 2015 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
