drugset / Trial / NCT01183208
A Safety and Tolerability Study of Administration of PSD502
Phase 1
Completed
21 enrolled
Plethora Solutions Ltd
Bio-Kinetic Europe, Ltd. · collabOmnicare Clinical Research · collab
RandomizedParallel-groupTriple-blindTreatment
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
Timeline
- Start
- 2009-12
- Primary completion
- 2010-02
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PSD502 | Other / unclassified | 3 mg | Topical |
| Subject | PSD502 | Other / unclassified | 30 mg | Topical |
| Subject | PSD502 | Other / unclassified | 150 mg | Topical |