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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022622
Receipt No. R000025870
Scientific Title A study to elucidate the effect of application conditions of a percutaneously absorbed type beta-1 blocker in healthy adults
Date of disclosure of the study information 2016/06/06
Last modified on 2016/08/13

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Basic information
Public title A study to elucidate the effect of application conditions of a percutaneously absorbed type beta-1 blocker in healthy adults
Acronym A study to elucidate the effect of application conditions of a percutaneously absorbed type beta-1 blocker in healthy adults
Scientific Title A study to elucidate the effect of application conditions of a percutaneously absorbed type beta-1 blocker in healthy adults
Scientific Title:Acronym A study to elucidate the effect of application conditions of a percutaneously absorbed type beta-1 blocker in healthy adults
Region
Japan

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

Objectives
Narrative objectives1 Confirmation of pharmacokinetics of bisonotape 4 mg under different application conditions (application site, application duration)
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Calculate pharmacokinetic parameters by application site and by application duration.
Parameters to be calculated: AUC24, Cmax, Tmax, t1/2, etc.
Key secondary outcomes Calculate the remaining amount and remaining ratio of the drug in a formulation by application site and by application duration. In addition, calculate the released amount and released ratio of the drug from the formulation.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One sheet of the study formulation is once applied to the chest for 24 hr
Interventions/Control_2 One sheet of the study formulation is once applied to the calf for 24 hr
Interventions/Control_3 One sheet of the study formulation is once applied to the lower abdominal region for 24 hr
Interventions/Control_4 One sheet of the study formulation is once applied to the chest and removed 4 hr after the application.
Interventions/Control_5 One sheet of the study formulation is once applied to the chest and removed 12 hr after the application.
Interventions/Control_6 One sheet of the study formulation is once applied to the chest and removed 24 hr after the application.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
35 years-old >=
Gender Male
Key inclusion criteria 1,Healthy male Japanese aged from 20 to 35 years old (at acquisition time of informed consent).
2,The person whose BMI [weight [kg]/(height [m])2] is 18.5 or more but less than 25.0 (cut off at 2 decimal places).
3,The person who is judged to be eligible as the study subjects for this study by a principal investigator or an investigator in charge of this study by taking into account the backgrounds of volunteers obtained in screening tests (medical history, allergy, favorite food and drinks, etc.), physical findings, results of physiological test, clinical examination values, etc.
Key exclusion criteria 1.Having disease to be cured now
2.Having drug/cutaneous allergy or its PH
3.Having disease affecting drug ADME in GIT, heart, liver, & kidney, or its PH
4.Having allergic diseases like asthma, pollen disease now
5.SBP is <90 mmHg or pulse rate <55/min at screening
6.Having PH of skin rash by external drugs 7.Having cutaneous diseases (e.g., dermatitis, pigment deposition, external injury) preventing from assessing effect at dose site
8.Having skin hair preventing from securing dose site, having tattoo/birthmark at the site, or often making sunburn his skin
9.Giving 400 mL oe more of WB within 12 W before dosing, giving 200 mL or more of WB or having such a plan within 4 W before dosing, or giving blood components or having such a plan within 2 W before dosing
10.Using a drug except said test drug or having such a plan within 1 W before dosing (except artificial tears)
11.Participating in another study and receiving a study drug or having such a plan within 16 W before dosing (within 4 W in a patch test)
12.Positive to any of immunological test item/deviating from its standard laboratory values at screening
13.Judged as undesirable as subject by principal investigator or investigator charged
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Takano
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Clinical Pharmacology Center
Zip code
Address 61-1 Shin-ei, Kiyota-ku, Sapporo-shi, Hokkaido, 006-0023 Japan
TEL 011-882-0111
Email info@ughp-cpc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryouta Wakimoto (Executive director of Study Office)
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Clinical Pharmacology Center
Zip code
Address 61-1 Shin-ei, Kiyota-ku, Sapporo-shi, Hokkaido, 006-0023 Japan
TEL 011-882-0111
Homepage URL
Email wakimoto@ughp-cpc.jp

Sponsor
Institute Toa Eiyo Ltd.
Institute
Department

Funding Source
Organization Toa Eiyo Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 医療法人北武会 美しが丘病院(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 06 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
2016 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 06 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 06 Month 06 Day
Last modified on
2016 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025870

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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