A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intr… (NCT00614029) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System
United States54 participantsStarted 2006-12
Plain-language summary
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
Who can participate
Age range18 Years – 55 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 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 select…
What they're measuring
1
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