UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011034
Receipt No. 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

* 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 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
Email

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
Email kotet@oita-u.ac.jp

Sponsor
Institute Dept. of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012917

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.