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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614029
• Other study ID #: ZX001-0601
• Status: Completed
• Phase: Phase 1
• Start date: December 2006

Study information

• Verified date: November 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioequivalence
• Pharmacokinetics

Intervention

Device:
• Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

Locations

Country	Name	City	State
United States	Covance, Inc	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zogenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one week