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| Sponsor: | Zogenix, Inc. |
|---|---|
| Information provided by: | Zogenix, Inc. |
| ClinicalTrials.gov Identifier: | NCT00620425 |
Purpose
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.
| Condition |
|---|
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Healthy |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | 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. |
| Enrollment: | 18 |
| Study Start Date: | December 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Healthy Volunteer Subjects
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Zogenix, Inc ( Stephen J. Farr, Ph.D/ President and COO ) |
| Study ID Numbers: | ZX001-0703 |
| Study First Received: | January 2, 2008 |
| Last Updated: | February 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00620425 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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sumatriptan Intraject Local Site Reactions |
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Serotonin Agonists Sumatriptan Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Physiological Effects of Drugs Vasoconstrictor Agents Cardiovascular Agents Pharmacologic Actions |