A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System
Information source: Zogenix, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics; Bioequivalence
Intervention: Sumatriptan (via Intraject System) (Device)
Phase: Phase 1
Status: Completed
Sponsored by: Zogenix, Inc. Official(s) and/or principal investigator(s):
Patricia Chandler, MD, Principal Investigator, Affiliation: Covance, Inc.
Summary
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the
Intraject system.
Clinical Details
Official title: A Randomized, Open-Label, Single-Dose, Four-Way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Versus IMITREX STATdose at Three Injection Sites in Healthy Adults
Study design: Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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
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.)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Covance, Inc, Dallas, Texas 75247, United States
Additional Information
Starting date: December 2006
Last updated: February 12, 2008
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