UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022622
Receipt number 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 08:01:43

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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 or person

Institute

Toa Eiyo Ltd.

Institute

Department

Personal name



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

Value
https://center6.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