Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults

Exclusion Criteria

• •Subject has suspected or confirmed cardiovascular disease that contraindicates study participation.
• •Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
• •Subject with Raynaud's disease.
• •Subject has a history of basilar or hemiplegic migraines.
• •Subject has a current diagnosis of a major depressive disorder per the Diagnostic and Statistical Manual of Mental Disorders version 4 revised (DSM-IV-R).
• •Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs, including Wellbutrin), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs) or preparations containing St. Joh's Wort within 1 month prior to screening and/or is planning to start any of these medications during the study and through the End of Study visit.
• •Subject is unwilling to discontinue use of a phosphodiesterase type 5 inhibitor (e.g. Viagra, Levitra, or Cialis) from screening through the End of Study visit.
• •Subject with a history of a significant allergy or hypersensitivity to any component of the study patch used in this study (NP101 formulation details can be found in the NP101 Investigator Brochure).
• •Subject who has any generalized skin irritation or disease including eczema, psoriasis, melanoma, acne or contact dermatitis.
• •Subject is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
• •Subject has hepatic dysfunction defined as SGOT/AST or SGPT/ALT greater than or equal to 2 times the upper limit of normal (ULN)range, or alkaline phosphatase or total bilirubin greater than or equal to 1.5 times the ULN range or if in the opinion of the Investigator the subject's history, physical examination or other laboratory tests suggest hepatic dysfunction.
• •Female subjects who are pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception during the study and for a period of 30 days following final dosing. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If the exclusive male partner is surgically sterile, this will be acceptable.
• •Subject has known history of tolerability issues with sumatriptan.
• •Subject who is considered by investigator or NuPathe, for any reason, to be an unsuitable candidate for this study.
• •Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.
• •Subject has participated in a clinical study within 30 days of screening.
• •Subject has clinically significant abnormal laboratory parameters, vial signs or ECG parameters.
• •Subject is electrically sensitive (e.g., prior iontophoresis with adverse outcome related to the current delivered by the device) or who have an implantable electronic device (e.g., pacemaker).