A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects

Inclusion criteria

• Subjects must be non-smokers, as defined by cessation of smoking and consumption of no more than 2 tobacco/nicotine-containing products within 6 months prior to screening.
• Have a body weight > 50 kg, and body mass index (BMI) of 18.0 to 38.0 kg/m2
• Free of any dermatologic conditions (eg, psoriasis, eczema), excessive hair, skin allergies, or sensitivities that may compromise the subject's ability to wear the investigational product at the application site for the specified duration of treatment
• Female subjects are eligible only if all the following apply:

• Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter
• Surgically sterile (via hysterectomy or oophorectomy); or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or have a same gender partner; or is using double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive for 3 months prior to the study, during the study, and for 1 month following the study
• Male subjects with female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 3 months following the study.

Exclusion criteria

• History of allergy or hypersensitivity to dexmedetomidine or dexmedetomidine hydrochloride.
• Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS application site, according to examination by the investigator at screening or admission to the clinic.
• History of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• History of seizures.
• Use of any prescription or non-prescription drugs (except acceptable forms of birth control, paracetamol up to 2 g per day for no more than 3 consecutive days, and ibuprofen up to 1.2 g per day for no more than 3 consecutive days for headache or dysmenorrhea, etc., per investigator discretion) within 14 days prior to study drug administration and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere
• Significant history of postural hypotension, or history of severe dizziness or fainting upon standing in the opinion of the investigator.
• Donation of blood or loss of blood (> 100 mL) within 30 days prior to study drug administration.
• Had symptoms of an upper respiratory tract infection within 14 days prior to dosing of the study drug