臨床研究等提出・公開システム

Scientific Title	Preliminary dermatopharmacokinetic study of flurbiprofen-containing tape (LC1702) in healthy adult males
Public Title	Preliminary dermatopharmacokinetic study of flurbiprofen-containing tape (LC1702) in healthy adult males

Contact for Scientific Queries	Name	Takazawa Kenji
	Affiliation	Medical Corporation Shinanokai Shinanozaka Clinic
	Address	3F Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo
	Telephone	+81-3-5366-3006
	E-mail	scl-irb@shinanokai.com
Contact for Public Queries	Name	Kurihara Noriko
	Affiliation	Tokyo Research Center of Clinical Pharmacology Co., Ltd.
	Address	Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo
	Telephone	+81-3-5366-3006
	E-mail	n-kurihara@trcp.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Oct. 23, 2023
Actual date of first enrollment
Target sample size		8
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Age: 20 to 40 years old (at the time of obtaining consent) (2) Persons whose BMI (Body Mass Index: weight (kg) / height (mm)2) is 18.5 kg/m2 or more and less than 25 kg/m2 (numbers are not rounded).
	Exclusion Criteria	(1) Persons with hypersensitivity or idiosyncrasy to drugs, etc. (2) Persons with a history of bronchial asthma. (3) Persons with diseases of the gastrointestinal tract, heart, liver, kidneys, etc. that affect drug metabolism and excretion. (4) Persons with have skin wounds at the administration site, and those who have skin symptoms such as eczema, contact dermatitis, psoriasis, seborrheic dermatitis, dyschromatosis, and excessive sunburn at the administration site.
	Age Minimum	20age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		healthy adult males
Intervention(s)		Single and repeated transdermal administration of LC1702 and ADF.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Calculation of drug amount in the stratum corneum
Secondary Outcome(s)

Primary Sponsor	LEAD CHEMICAL Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	Oct. 10, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history