UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Rikkunshito on the Pharmacokinetics of Digoxin
Title of the study (Brief title)	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	Junichi Hasegawa
Organization	Tottori University Faculty of Medicine
Division name	Pharmacotherapeutics
Address	86 Nishicho, Yonago
TEL	0859-38-6171
Email	hasegawa@med.tottori-u.ac.jp

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

Sponsor
Institute	Tottori University Faculty of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019288