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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013106
Receipt No. R000015248
Scientific Title Effects of Daijokito on the pharmacokinetics of H2 blocker ranitidine.
Date of disclosure of the study information 2014/02/14
Last modified on 2014/08/07

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Basic information
Public title Effects of Daijokito on the pharmacokinetics of H2 blocker ranitidine.
Acronym Daijokito effects on pharmacokinetics of ranitidine
Scientific Title Effects of Daijokito on the pharmacokinetics of H2 blocker ranitidine.
Scientific Title:Acronym Daijokito effects on pharmacokinetics of ranitidine
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the drug-interaction between Kanpo medical formula and western drugs
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pharmacokinetics of ranitidine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Daijokito 2.5g
Interventions/Control_2 ranitidine 300mg
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
50 years-old >
Gender Male
Key inclusion criteria healthy volunteer without diseases except for constipation
Key exclusion criteria easily to have loose bowels, smoker
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Hasegawa
Organization Faculty of Medicine, Tottori University
Division name Pharmacotherapeutics
Zip code
Address 86 Nishicho, Yonago
TEL 0859-38-6171
Email hasegawa@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Hasegawa
Organization Tottori University
Division name Pharmacotherapeutics
Zip code
Address 86 Nishicho, Yonago
TEL 0859-38-6171
Homepage URL
Email hasegawa@med.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization Tottori 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
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 鳥取大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 14 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 An apparent drug-interaction was observed
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 02 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 10 Day
Last follow-up date
2014 Year 04 Month 10 Day
Date of closure to data entry
2014 Year 07 Month 11 Day
Date trial data considered complete
2014 Year 07 Month 11 Day
Date analysis concluded
2014 Year 07 Month 16 Day

Other
Other related information Results will be reported at 35th annual meeting of the Japanese Clinical Pharmacology and Therapeutics.

Management information
Registered date
2014 Year 02 Month 07 Day
Last modified on
2014 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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