Clinical Trial: Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers
Brief Summary: To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.
Detailed Summary: The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.
Sponsor: Laboratoires Thea
Current Primary Outcome:
- Area Under the Curve from 0 to 24 hours (AUC0-24h)
- Elimination half-life (t1/2)
- Maximum Concentration (Cmax)
- Concentration 24 hours after instillation (C24h)
Original Primary Outcome: Same as current
Current Secondary Outcome: Tolerance
Original Secondary Outcome: Same as current
Information By: Laboratoires Thea
Dates:
Date Received: July 25, 2006
Date Started: May 2002
Date Completion: June 2002
Last Updated: July 25, 2006
Last Verified: July 2006
