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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.
This is a single-centre, non-randomised, open-label, single-dose, three-period study planned to include eight healthy female volunteers. Subjects will attend a screening visit within 21 days of dosing. In Period 1, an intravenous dose of HAL 0.4 mg/kg including 100 nCi (3.7 kBq) 14C will be infused over a one hour period. In Period 2, a vaginal dose HAL 150 mg including 13,9 kBq of 14C HAL will be administered for 7 hours. In period 3, following a colon cleaning, 100mg HAL enema including 14,8 kBq of 14C will be instilled for 30 minutes in 8 subjects. Period 1, 2 and Period 3 will be conducted in an identical manner except that subjects will receive the HAL by different dose routes. Blood samples will be drawn during 3 days of follow up to evaluate the single dose pharmacokinetics of HAL for each dose route. In addition, urine and faeces will be collected from Period 1. The urine and faces samples will be stored for possible future analysis.
There will be a minimum of 7 days washout between the three dosing periods. Subjects will attend a final follow-up visit at the 14 day blood sampling visit in the third study period. The total amount of 14C-label used in each volunteer is estimated to be approximately 33.3 kBq. No formal calculation of the radiation burden was made. Based on data of full-dose ADME studies it is estimated that this dose will give a radiation burden of less than 0.01 mSv, which falls in ICRP category I: trivial risk.
Diagnosis and main criteria for inclusion:
Healthy female subjects aged 18 to 55 years (inclusive) with body mass index (BMI) >19 and <30 kg/m2 who give written informed consent and comply with all the inclusion and exclusion criteria, will be entered into the study.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label
Published on BioPortfolio: 2014-08-27T03:16:38-0400
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