Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects
Status:
Completed
Trial end date:
2015-12-15
Target enrollment:
Participant gender:
Summary
This will be a single center, open-label, single dose, randomized and 2-way crossover study
in healthy Japanese male subjects under fasting conditions. The study will be conducted to
determine the bioequivalence between dutasteride capsules manufactured at GSK (test product)
and dutasteride capsule manufactured at Catalent (reference product) in healthy Japanese male
subjects. Subjects will have a screening visit within 30 days prior to the first dose of
study treatment, two treatment periods separated by 28-days washout period, a re-visit 10-14
days after the second dose for the first follow-up and a second follow up via telephone 50-54
days after the second dose. The total duration of the study will be approximately 15 weeks
from screening to the second follow up.