Pharmacokinetic controlled trial of NZT-235

JRCT ID: jRCT2071200116

Registered date:23/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pain relief from postherpetic neuralgia
• Date of first enrollment: 08/04/2021
• Target sample size: 33
• Study type: Interventional

Intervention(s)

Step1
Apply three investigational drugs to the back for 12 hours.
Blood is collected for measuring plasma drug concentration.

Step2
Three investigational drugs are applied to the back for 12 hours repeatedly for 7 days.
Blood is collected for measuring plasma drug concentration.

Outcome(s)

Primary Outcome

Pharmacokinetics
Plasma NZT-235 concentration

Secondary Outcome

Pharmacodynamics
safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1) Japanese healthy adult male applicants aged between 20 and 45 at the time of consent acquisition
2) Those who have received sufficient explanation about the content of this clinical trial and obtained their written consent.
3) Persons weighing 50 kg or more at the time of screening test

Exclude criteria

1) Those who have skin diseases or skin abnormalities (dermatitis, eczema, pimples, dyschromia, etc.) at the application site
2) Persons with a history of skin allergies (persons with hypersensitivity to transdermal preparations)
3) Persons who routinely use external preparations such as coating agents, patches, and aerosols on the application site
4) If there are disorders in the gastrointestinal tract, heart, liver, kidneys, blood, respiratory organs, etc. that are thought to affect pharmacokinetics and safety, or if their history interferes with clinical trial participation, judged by Principal investigator (Subinvestigator )
5) Those who have hypersensitivity or idiosyncratic constitution to drugs

Related Information

• Primary Sponsor: Taira Kayo