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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023024
Receipt No. R000026536
Scientific Title Evaluation of pharmacokinetics of bisoprolol after apprication of a bisoprolol patch preparation for an 8 h.
Date of disclosure of the study information 2016/07/15
Last modified on 2017/04/07

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Basic information
Public title Evaluation of pharmacokinetics of bisoprolol after apprication of a bisoprolol patch preparation for an 8 h.
Acronym Evaluation of pharmacokinetics of bisoprolol after apprication of a bisoprolol patch preparation for an 8 h.
Scientific Title Evaluation of pharmacokinetics of bisoprolol after apprication of a bisoprolol patch preparation for an 8 h.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuhiko Nagai
Organization Kaetsu Hospital
Division name Department of Pharmacy
Zip code
Address 1159-1, Higashikanazawa, Akiha-ku, Niigata
TEL 0250-22-4711
Email nagai_k@niigata-min.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Ueno
Organization Niigata University of Pharmacy and Applied Life Sciences
Division name Department of Clinical Pharmacokinetics, Faculty of Pharmaceutical Sciences
Zip code
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)

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

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

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2016 Year 03 Month 22 Day
Date of IRB
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

Other
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

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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