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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000016656
Date of registration:	27/02/2015
Prospective Registration:	Yes
Primary sponsor:	Tottori University Faculty of Medicine
Public title:	Effects of Rikkunshito on the Pharmacokinetics of Digoxin
Scientific title:	Effects of Rikkunshito on the Pharmacokinetics of Digoxin - Rikkunshito Effects on Digoxin Pharmacokinetics
Date of first enrolment:	2015/03/16
Target sample size:	6
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019288
Study type:	Interventional
Study design:	Cross-over Randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:	Junichi Hasegawa
Address:	86 Nishicho, Yonago Japan
Telephone:	0859-38-6171
Email:	hasegawa@med.tottori-u.ac.jp
Affiliation:	Tottori University Faculty of Medicine Pharmacotherapeutics

Name:	Junichi Hasegawa
Address:	86 Nishicho, Yonago Japan
Telephone:	0859-38-6171
Email:	hasegawa@med.tottori-u.ac.jp
Affiliation:	Tottori University Faculty of Medicine Pharmacotherapeutics

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Volunteer with history of psychiatric disorder and alcohol poisoning

Age minimum: 20years-old
Age maximum: 50years-old
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Male Volunteer

Intervention(s)

Multiple dose of Rikkunshito 2.5 g
Single dose of Digoxin 0.25 mg

Primary Outcome(s)

Digoxin pharmacokinetics

Secondary Outcome(s)

Safety

Secondary ID(s)

Source(s) of Monetary Support

Tottori University Hospital

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	15/04/2016
URL:

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