NCT00614029

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.)

Conditions

• Pharmacokinetics
• Bioequivalence

Interventions

Type	Name	Description
DEVICE	Sumatriptan (via Intraject System)	0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt

Timeline

• Start date: 2006-12-01
• Primary completion: 2006-12-01
• First posted: 2008-02-13
• Last updated: 2022-11-10

Locations

1 site across 1 country: United States