Bioequivalence, Pharmacokinetics
Conditions
Keywords
sumatriptan, Injections, Subcutaneous
Brief summary
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
Detailed description
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.)
Interventions
DEVICESumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Sponsors
Zogenix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed