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

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Pharmacokinetics
Interventions
DRUG

hexaminolevulinate (HAL)

Intravenous dose of HAL 0.4 mg/kg including 100 nCi (3.7 kBq) 14C infused over a one hour period. A vaginal dose HAL 150 mg including 13,9 kBq of 14C HAL will be administered for 7 hours. Following a colon cleaning, 100mg HAL enema including 14,8 kBq of 14C will be instilled for 30 minutes in colon

Trial Locations (1)

9471

Pra-Eds-Nl, Zuidlaren

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Photocure

INDUSTRY