A study of pharmacokinetics and safety on repeated application of flurbiprofen-containing patch (Tape) (LC1702) in healthy adult males.

JRCT ID: jRCT2031240583

Registered date:26/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Pain relief and anti-inflammation
• Date of first enrollment: 10/01/2025
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Repeated transdermal application of LC1702 and ADF.

Outcome(s)

• Primary Outcome: Drug concentration in plasma

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Male

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Takazawa Kenji