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

Completed · Phase 1

Conditions studied: Pharmacokinetics, Bioequivalence

In brief

A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.

Key facts

Study ID

NCT00614029

Run by

Zogenix, Inc.

People needed

54

Starts

2006-12-01

Last updated by the study team

2022-11-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance, Inc — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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