A Randomized, Open Label, Crossover, Bioavailability Study to Compare Omexa Sumatriptan Transmucosal Sublingual Tablet Versus Commercial Imitrex® Sumatriptan Oral Tablet in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Omexa Sublingual Sumatriptan tablet
- Conditions
- Migraine
- Sponsor
- Targia Pharmaceuticals Ltd.
- Enrollment
- 13
- Primary Endpoint
- Peak Plasma concentration (Cmax)
- Last Updated
- 9 years ago
Overview
Brief Summary
the trial is a randomized, open label, crossover, single-administration bioavailability study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual tablet versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers.
Detailed Description
Volunteers will randomly receive either the commercial oral tablet 100 mg Imitrex® or 75 mg Omexa sublingual tablet under fasted conditions. One week following the first administration, the volunteers will receive the alternative treatment. Blood samples will be collected at each visit before drug administration and at 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min after drug administration, in order to characterize the drug's absorption and pharmacokinetics, as well as to evaluate Omexa formulation safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide written informed consent
- •Man and women volunteers 18-55 years of age
- •Healthy with no clinically relevant abnormalities in the opinion of the investigator as determined by medical history, physical examination, urine analysis and vital signs.
- •Have a BMI of 18-32 kg/m2, inclusive, and a body weight of not less than 50 kg
- •Women of child-bearing potential who agree to use double contraceptive 14 days prior to the study, during whole duration of the study and 30 days after completion of the study.
- •The volunteer agrees to abstain from alcohol intake 48 hours before each administration of study agent and during inpatient portion of the study
- •The volunteer agrees not to consume food or beverages containing, grapefruit or grapefruit juice 72 hours prior to study treatment and until after the last pharmacokinetic (PK) sample is collected
- •The volunteer agrees to frequent blood withdrawal
- •The volunteer doesn't have history of fear of needles and injections, or hemophobia (fear of blood)
Exclusion Criteria
- •Pregnant or breast-feeding women (women of child bearing potential must use double contraceptive and have the results of a negative pregnancy test recorded prior to study drug administration)
- •Have a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •Volunteers with two or more risk factors for ischemic heart disease
- •History of seizures
- •History of moderate to severe hypertension or mild uncontrolled hypertension or systolic blood pressure above 140 or diastolic above 90 during screening visit
- •Currently or history of disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system that is clinically significant in the opinion of the Investigator.
- •History of hypersensitivity or allergies to any drug compound, including Sumatriptan, any of its components or sulphonamides (Appendix 1).
- •History of traumatic surgery within 12 weeks prior to screening, pre-planned surgery or procedures that would interfere with the conduct of the study.
- •Have an acute illness within 7 days prior to study treatment or have had a major illness or hospitalization within 1 month prior to study treatment.
- •History (within 1 year) of alcohol or drug abuse.
Arms & Interventions
75 mg Omexa sumatriptan sublingual tablet
Intervention: Omexa Sublingual Sumatriptan tablet
100 mg Imitrex oral tablet
Intervention: Imitrex Oral Product
Outcomes
Primary Outcomes
Peak Plasma concentration (Cmax)
Time Frame: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Time to reach peak plasma concentration (Tmax)
Time Frame: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Area under the curve (AUC)
Time Frame: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Secondary Outcomes
- Adverse events(Through study completion, an average of 2 months)