A Safety and Tolerability Study of Administration of PSD502
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group,
Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to
Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine;
and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following
Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of
PSD502 or Placebo
Phase:
Phase 1
Details
Lead Sponsor:
Plethora Solutions Ltd
Collaborators:
Bio-Kinetic Europe, Ltd. Omnicare Clinical Research