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Scientific Title	A study of pharmacokinetics and safety on repeated application of flurbiprofen-containing patch (Tape) (LC1702) in healthy adult males.
Public Title	A study of pharmacokinetics and safety on repeated application of flurbiprofen-containing patch (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	n-kurihara@trcp.co.jp
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	Recruiting

Anticipated date of first enrollment		Jan. 10, 2025
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	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Age: 18 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/m^2 or more and less than 25 kg/m^2 (numbers are not rounded) (3) Persons who can quit smoking during their stay
	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 skin wounds at the application site, and those who have skin symptoms such as eczema, contact dermatitis, psoriasis, seborrheic dermatitis, dyschromatosis, and excessive sunburn at the application site.
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Pain relief and anti-inflammation
Intervention(s)		Repeated transdermal application of LC1702 and ADF.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Drug concentration in plasma
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	Dec. 10, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 14, 2025	(this page)	Changes
1	Dec. 26, 2024	Detail

List of change history