Trials / Completed

CompletedNCT00620425

A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs

A Single-Center, Open-label, Single-Arm Study to Evaluate the Effects of Repeat Doses of Subcutaneously Delivered Sumatriptan Via the Intraject System of Local Injection Site Signs in Healthy Adult Subjects.

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 18 (actual)

Sponsor: Zogenix, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.

Detailed description

This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.

Conditions

Healthy

Interventions

Type	Name	Description
DRUG	Sumatriptan	injection

Timeline

Start date: 2007-12-01
Primary completion: 2007-12-01
Completion: 2007-12-01
First posted: 2008-02-21
Last updated: 2023-05-09
Results posted: 2012-07-17

Source: ClinicalTrials.gov record NCT00620425. Inclusion in this directory is not an endorsement.