UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of pharmacokinetics of bisoprolol after apprication of a bisoprolol patch preparation for an 8 h.
Title of the study (Brief title)	Evaluation of pharmacokinetics of bisoprolol after apprication of a bisoprolol patch preparation for an 8 h.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate drug release from a bisoprolol patch preparation and its pharmacokinetics after an 8 h apprication.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetic parameter
Key secondary outcomes	Release from preparation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Application of a patch preparation containing 4 mg bisoprolol for 8 h
Interventions/Control_2
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	Not applicable
Gender	Male
Key inclusion criteria	1. Healthy male Japanese. 2. Volunteers being able to make self-judgment to participate in this study and giving written informed consent. 3. Volunteers judged to be appropriate for this study by chief doctor.
Key exclusion criteria	1. Having disease to be cured now. 2. Having drug/cutaneous allergy or its past history. 3. Volunteers rejected participating in this study by chief doctor.
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuhiko Nagai
Organization	Kaetsu Hospital
Division name	Department of Pharmacy
Address	1159-1, Higashikanazawa, Akiha-ku, Niigata
TEL	0250-22-4711
Email	nagai_k@niigata-min.or.jp

Public contact
Name of contact person	Kazuyuki Ueno
Organization	Niigata University of Pharmacy and Applied Life Sciences
Division name	Department of Clinical Pharmacokinetics, Faculty of Pharmaceutical Sciences
Address	265-1, Higashizima, Akiha-ku, Niigata
TEL	0250-25-5278
Homepage URL
Email	uenok@nupals.ac.jp

Sponsor
Institute	Kaetsu Hospotal
Institute
Department

Funding Source
Organization	Niigata University of Pharmacy and Applied Life Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2017 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026536