Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects (ARI115148)
The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Single Dose, Randomized, Two-period Crossover Study to Investigate the Bioavailability of a Novel Dosage Form of Dutasteride in Healthy Male Subjects|
- Bioavailability [ Time Frame: Change from Day 1 (session 1) compared to Day 29 (session 2), predose, .25, .5, .75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 ] [ Designated as safety issue: No ]To assess the dutasteride relative bioavailability of the of 0.5 mg novel formulation compared with the currently marketed 0.5 mg soft gelatin capsule.
- Safety [ Time Frame: Changes from screening to 3 months ] [ Designated as safety issue: No ]Changes in blood pressure and pulse rates, review of number of subjects with adverse events, and changes in clinical laboratory data.
|Study Start Date:||May 2011|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: 0.5 mg novel dose form (test)
0.5 mg novel dose form (test)
0.5 mg Soft Gel Capsule
0.5 mg Soft Gel Capsule (reference)
dutasteride soft gel capsule
The purpose of this study is to determine the bioavailability of 0.5mg dutasteride in a novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects. This will be an open-label, single dose, randomized, two-period crossover study in healthy male subjects. Subjects will receive a single oral dose 0.5mg novel dutasteride formulation and a single oral dose 0.5mg dutasteride soft gel capsule in a fasted state. Each dose of the study medication will be separated by a 28-day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, laboratory data, and review of adverse events. The study will enrol approximately 35 healthy male subjects to ensure that 30 subjects complete the study. The study will be conducted in the USA.