UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014773 |
|---|---|
| Receipt number | R000017140 |
| Scientific Title | The effect of apple juice on the pharmacokinetics of fexofenadine -evaluation of dose-effect relationship- |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2015/11/19 09:23:00 |
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Basic information
Public title
The effect of apple juice on the pharmacokinetics of fexofenadine -evaluation of dose-effect relationship-
Acronym
The effect of apple juice on the pharmacokinetics of fexofenadine
Scientific Title
The effect of apple juice on the pharmacokinetics of fexofenadine -evaluation of dose-effect relationship-
Scientific Title:Acronym
The effect of apple juice on the pharmacokinetics of fexofenadine
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
to evaluate the relationship between volume of apple juice intake and phaemacokinetics of fexofenadine
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacokinetic parameters of fexofenadine after oral administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
apple juice 150mL
Interventions/Control_2
apple juice 300mL
Interventions/Control_3
apple juice 600mL
Interventions/Control_4
water 600mL
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. person who is healthy
2. person who provides consent and signs up the consent form
Key exclusion criteria
1. person who has some acute or chronic disease that requires medical treatment
2. person who is taking any medicine or dietary supplement
3. person who has drug or any kind of allergy
4. BMI <18 or >28
5. systolic blood pressure <90mmHg or >150mmHg
6. person who shows any abnormal data in hematological and biochemical blood analysis or urinalysis
7. person who is pregnant or doing breast feeding, or do not agree with anticonception during the trial
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Imai |
Organization
Oita University Hospital
Division name
Clinical Pharmacology Center
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 Hospital
Division name
Clinical Pharmacology Center
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
Clinical Pharmacology Center, Oita University Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinical Pharmacology Center, Oita University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 05 | 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
| 2014 | Year | 08 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017140
