UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016656 |
|---|---|
| Receipt number | R000019288 |
| Scientific Title | Effects of Rikkunshito on the Pharmacokinetics of Digoxin |
| Date of disclosure of the study information | 2015/02/27 |
| Last modified on | 2017/02/27 10:14:54 |
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Basic information
Public title
Effects of Rikkunshito on the Pharmacokinetics of Digoxin
Acronym
Rikkunshito Effects on Digoxin Pharmacokinetics
Scientific Title
Effects of Rikkunshito on the Pharmacokinetics of Digoxin
Scientific Title:Acronym
Rikkunshito Effects on Digoxin Pharmacokinetics
Region
| Japan |
Condition
Condition
Healthy Male 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
Not applicable
Assessment
Primary outcomes
Digoxin pharmacokinetics
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Multiple dose of Rikkunshito 2.5 g
Interventions/Control_2
Single dose of Digoxin 0.25 mg
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 male volunteer
Key exclusion criteria
Volunteer with history of psychiatric disorder and alcohol poisoning
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Hasegawa |
Organization
Tottori University Faculty of Medicine
Division name
Pharmacotherapeutics
Zip code
Address
86 Nishicho, Yonago
TEL
0859-38-6171
hasegawa@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Hasegawa |
Organization
Tottori University Faculty of Medicine
Division name
Pharmacotherapeutics
Zip code
Address
86 Nishicho, Yonago
TEL
0859-38-6171
Homepage URL
hasegawa@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tottori University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
鳥取大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 27 | 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
| 2015 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 27 | Day |
Last modified on
| 2017 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019288
