UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006072 |
|---|---|
| Receipt number | R000007184 |
| Scientific Title | Effect of grapefruit juice on activities of metabolic enzyme and transporter in healthy volunteers. |
| Date of disclosure of the study information | 2011/07/29 |
| Last modified on | 2011/07/29 14:37:31 |
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Basic information
Public title
Effect of grapefruit juice on activities of metabolic enzyme and transporter in healthy volunteers.
Acronym
Effect of grapefruit juice on activities of metabolic enzyme and transporter in healthy volunteers.
Scientific Title
Effect of grapefruit juice on activities of metabolic enzyme and transporter in healthy volunteers.
Scientific Title:Acronym
Effect of grapefruit juice on activities of metabolic enzyme and transporter in healthy volunteers.
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the inhibitory effect of grapefruit juice on pharmacokinetics and pharmacodynamics of celiprolol and midazolam
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
pharmacokinetics of celiprolol and midazolam, blood pressure, heart rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
oral administration of celiprolol, midazolam and grapefruit juice
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
capable of understanding and adhering to the protocol
Key exclusion criteria
Blood pressure <= 100 mmHg
Heart rate <= 50 mmHg
Abnormality on laboratery tests and ECG
Continual intake of drug or supplement
Patients with chronic asthma and diabetic mellitus
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University, School of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Uchida |
Organization
University of Shizuoka, School of Pharmaceutical Sciences
Division name
Department of Pharmacy Practice & Science
Zip code
Address
Yada 52-1, Suruga-ku, Shizuoka, 422-8526, JAPAN
TEL
054-264-5234
Homepage URL
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
School of Pharmaceutical Sciences,
University of Shizuoka
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
浜松医科大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2011 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007184
