Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers

Exclusion Criteria

• •Subject has a history of allergy or hypersensitivity to any component of the study patch used in this study.
• •Subject has any generalized skin irritation or disease including eczema, psoriasis, melanoma, contact dermatitis or acne.
• •Subject has a tattoo that might interfere with skin irritation examination.
• •Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
• •Subject has a history of basilar or hemiplegic migraines.
• •Subject has suspected or confirmed cardiovascular disease that contraindicates participation.
• •Subject has Raynaud's disease.
• •Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence.
• •Subject with a history of malignancy within the past 5 years.
• •Subject has clinically significant abnormal laboratory parameters, vital signs or ECG parameters.
• •Subject has SGOT/AST, SGPT/ALT, alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal.
• •Subject with a hemoglobin (Hgb) level of less than 7.5 mmol/L.
• •Subject is hepatitis B, hepatitis C or HIV positive.
• •Subject has taken an MAO inhibitor, preparations containing St. John's Wort, SSRI, SNRI, TCA, triptan or ergot medication, within one month prior to screening.
• •Subject is unwilling to discontinue the use of phosphodiesterase type 5 inhibitor, from screening through the End of Study.
• •Subject who has been administered an injectable drug, except for local anesthetic or birth control, within 30 days prior to the initial study drug administration.
• •Donation of blood or blood products within 8 weeks prior to study entry.
• •Receipt of an investigational drug or participation in any clinical study within 90 days prior to study.
• •Subject who requires any medication on a regular basis, with the exception of steroidal contraceptives.
• •Concurrent use of Rx or OTC medications or natural medicine (herbal) products, with the exception of steroidal contraceptives.
• •Female subject who is pregnant, planning a pregnancy during the study, breast feeding; or if of childbearing potential, not using or unwilling to use an effective form of contraception during the study and for a period of 30 days following dosing.
• •Subject who is considered to be an unsuitable candidate for receiving sumatriptan, or as being unsuitable for any other reason.
• •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).