drugset / Trial / NCT01050309
An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers
Non-randomizedSingle-groupOpen-label
Summary
The study will determine the extent of systemic absorption of HAL following vaginal and enema administration compared to intravenous administration to healthy female volunteers. In addition, the pharmacokinetic parameters for the combined level of 14C labelled substances (sum of parent and possible metabolites)will be assessed. The safety and tolerability of HAL following vaginal, enema and intravenous administration to healthy female volunteers will be investigated.
Timeline
- Start
- 2009-11
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | hexaminolevulinate | Small molecule | 0.4 mg/kg | Intravenous |
| Comparator | hexaminolevulinate | Small molecule | 100 mg | Intravenous |
| Comparator | hexaminolevulinate | Small molecule | 150 mg | Intravenous |
Indications
No indication recorded.