UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011034 |
|---|---|
| Receipt number | R000012917 |
| Scientific Title | Effect of timing of apple juice intake on the pharmacokinetics of fexofenadine: an open-label, randomized study in healthy volunteers |
| Date of disclosure of the study information | 2013/06/25 |
| Last modified on | 2014/08/26 11:03:14 |
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Basic information
Public title
Effect of timing of apple juice intake on the pharmacokinetics of fexofenadine: an open-label, randomized study in healthy volunteers
Acronym
Effect of timing of apple juice intake on the pharmacokinetics of fexofenadine in humans
Scientific Title
Effect of timing of apple juice intake on the pharmacokinetics of fexofenadine: an open-label, randomized study in healthy volunteers
Scientific Title:Acronym
Effect of timing of apple juice intake on the pharmacokinetics of fexofenadine in humans
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether administration timing of apple juice affects the pharmacokinetics of fexofenadine
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharmacokinetic parameters of fexofenadine
Key secondary outcomes
Adverse reactions of fexofenadine
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)fexofenadine only with water (control), 2)fexofenadine administration 0 hours after apple juice intake, 3)fexofenadine administration 3 hours after apple juice intake, 4)fexofenadine administration 1 hours after apple juice intake
Interventions/Control_2
1)fexofenadine administration 0 hours after apple juice intake, 2)fexofenadine administration 1 hours after apple juice intake, 3)fexofenadine only with water (control), 4)fexofenadine administration 3 hours after apple juice intake
Interventions/Control_3
1)fexofenadine administration 1 hours after apple juice intake, 2)fexofenadine administration 3 hours after apple juice intake, 3)fexofenadine administration 0 hours after apple juice intake, 4)fexofenadine only with water (control)
Interventions/Control_4
1)fexofenadine administration 3 hours after apple juice intake, 2)fexofenadine only with water (control), 3)fexofenadine administration 1 hours after apple juice intake, 4)fexofenadine administration 0 hours after apple juice intake
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
Key inclusion criteria
1) A subject with body weight between 50 kg (inclusive) and 90 kg (exclusive) and body mass index (BMI) between 17 (inclusive) and 28 (exclusive)
2) Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (including the case that the investigator considers the deviation to be irrelevant for the purpose of the study)
Key exclusion criteria
1) A subject with history of allergies including study drug (fexofenadine) or other drug allergies, or history of clinically significant allergies
2) A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, gastrointestinal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
3)A subject who shows a positive reaction to any one of serology tests (hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody)
4)A subject with a history of surgery (except simple appendectomy or repair of hernia)
5)A subject with history of drug abuse or positive urine drug screening test
6)A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.)
7)A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration
8)A subject who has donated or had loss of 400 mL or more of blood within 8 weeks prior to start of administration of study drug
9)A subject who consumes more than 7 units of alcohol (140g) per week or unable to stop drinking throughout the study period
10)A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months)
11)A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Kotegawa |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL
097-586-5952
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Kotegawa |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL
097-586-5952
Homepage URL
kotet@oita-u.ac.jp
Sponsor or person
Institute
Dept. of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
大分大学医学部附属病院総合臨床研究センター (General Clinical Research Center, Oita University Hospital)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 25 | 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
| 2013 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2014 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012917
