A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
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.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
54
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
Covance, Inc
Dallas, Texas, United States
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
Time frame: one week
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