NCT01577693

Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	dutasteride	novel dutasteride
DRUG	dutasteride	dutasteride soft gel capsule

Timeline

• Start date: 2011-05-12
• Primary completion: 2011-08-31
• Completion: 2011-08-31
• First posted: 2012-04-16
• Last updated: 2018-06-19

Locations

1 site across 1 country: United States