UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006072
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007184

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.