Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System
Lead Sponsor:
Zogenix, Inc.
Conditions:
Pharmacokinetics
Bioequivalence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 sumatript...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00614029
Start Date
December 1 2006
Last Update
November 10 2022
Active Locations (1)
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1
Covance, Inc
Dallas, Texas, United States, 75247