A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System

Study Overview
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Brief Summary
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A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.

Detailed Description
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A single center, randomized, single-dose, open-label, partial-block, four-period, four-way crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)

Official Title
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A Randomized, Open-Label, Single-Dose, Four-way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Versus IMITREX STATdose at Three Injection Sites in Healthy Adults

Conditions
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Pharmacokinetics, Bioequivalence

Intervention / Treatment
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* Device: Sumatriptan (via Intraject System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Negative serum pregnancy test Female subjects of child-bearing potential must agree to use acceptable birth control 3 weeks prior to and 2 weeks after study dosing. Body Mass Index (BMI) and sufficient subcutaneous thickness, in the opinion of the investigator, for an injection into the abdomen, arm and thigh Non-tobacco user Adequate venous access in the left or right arm to allow collection of a number of blood samples Fluent in the English language Provide written informed consent to participate in the study and be willing to comply with the study procedures Exclusion Criteria: History within the previous 2 years of drug or alcohol dependence Evidence of clinically relevant oral, cardiovascular, hematologic, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder History of epilepsy or other neurologic disease History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension, or signs/symptoms of ischemic heart disease History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or similar drugs including sulphonamides History of scleroderma or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications Tattoos or birthmarks in the lateral thigh, abdominal area or arm (deltoid) that are large enough to restrict injection site selection and/or evaluation Positive screening test for HIV antibodies, Hepatitis B surface antigen, or Hepatitis C antibody Positive results on illicit drug test at Screening or at Check-in Use of any prescription medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh | Device: Sumatriptan (via Intraject System)<br>* 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt<br>|
| Experimental: B<br>Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh | Device: Sumatriptan (via Intraject System)<br>* 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt<br>|
| Experimental: C<br>Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm. | Device: Sumatriptan (via Intraject System)<br>* 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt<br>|
| Experimental: D<br>IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm. | Device: Sumatriptan (via Intraject System)<br>* 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt<br>|
| Experimental: E<br>IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh | Device: Sumatriptan (via Intraject System)<br>* 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt<br>|
| Experimental: F<br>Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm | Device: Sumatriptan (via Intraject System)<br>* 0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the plasma concentration-time curve, maximal plasma concentration, time to maximal concentration, terminal elimination half-life, and apparent terminal elimination rate constant of sumatriptan will be determined at each of 3 sites |  | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sumatriptan, Injections, Subcutaneous