Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulatio… (NCT00546650) | Clinical Trial Compass
CompletedPhase 1
Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®
United States25 participantsStarted 2007-11
Plain-language summary
The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy men or women aged 18 to 65 years.
* Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the study, and must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 for all periods.
* Subjects must have body mass index (BMI) of 18 to 30 kg/m2 inclusive.
* Subjects must be able to communicate effectively with the study personnel.
* Subjects must have, in the investigator's opinion, no clinically significant disease or abnormal laboratory values as determined by medical and psychiatric history, physical examination, or laboratory evaluations conducted at the screening visit or on clinic admission.
* Subjects must have a 12-lead ECG without any clinically significant abnormalities of rate, rhythm, intervals or conduction, as determined by the investigator.
* Subjects must be nonsmokers, defined as having not used any tobacco products in the 6 months before screening.
* Subjects must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or grapefruit juice within 72 hours prior to admission to the clinic for Period 1 and for the duration of the study.
* Subjects must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
* The subject must be likely to complete the entire study.
Exclusion Criteria:
* Female subjects who are pregnant or breast feeding or planning a pregnancy durin…
What they're measuring
1
Pharmacokinetics
Timeframe: Blood samples to be drawn at pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 16 hrs post dose.