NCT00895076

Study to Compare the Pharmacokinetics of a Dexamethasone Iontophoretic Patch to a Dexamethasone Injection

A Randomized, Open-Label, Single Dose, Two-Way Crossover Study to Evaluate the Pharmacokinetics and Safety of a Dexamethasone Iontophoretic Transdermal Patch Compared to Dexamethasone Injection in Healthy Adult Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Travanti Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objectives are to evaluate the extent of systemic exposure and dexamethasone bioavailability following a single application of a dexamethasone iontophoretic transdermal patch in healthy volunteers. The secondary objectives are to evaluate the systemic and topical safety of the dexamethasone iontophoretic transdermal patch and of the dexamethasone intramuscular (IM) injection.

Conditions

• Lateral Epicondylitis (Tennis Elbow)

Interventions

Type	Name	Description
DRUG	dexamethasone	iontophoretic patch and injection

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-05-07
• Last updated: 2009-05-07

Locations

1 site across 1 country: United States