Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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)
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||June 2002|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356850
|Principal Investigator:||Claude DUBRAY, Professor||Centre de Pharmacologie Clinique - Clermont-Ferrand (France)|