Clinical Trial: Study to Compare Different Formulations of AZD3355

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae

Brief Summary: The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Specific AE questions [ Time Frame: During 0-4 hours post dose ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • PK variables [ Time Frame: Frequent sampling up to 36 hours post dose ]
  • Safety variables (other adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]


Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: May 30, 2008
Date Started: April 2008
Date Completion:
Last Updated: December 2, 2010
Last Verified: December 2010