Clinical trial NCT00614029: A Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Bioequivalence
Keywords: sumatriptan
Injections
Subcutaneous
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance, Inc
state: Texas
Study officials:
affiliation: Covance
name: Patricia Chandler, MD
role: PRINCIPAL_INVESTIGATOR
References: