Healthy Clinical Trial
Official title:
A Single-dose, Open-label, Randomised, Crossover Bioequivalence Study in Healthy Young Men Comparing Two Formulations of Escitalopram
This is a bioequivalence study, which is a regulatory requirement to ensure comparable in
vivo performance, i.e. similarities in terms of safety and efficacy, after administration of
two different dosage forms of escitalopram.
All subjects will receive three separate dosages of 20 mg escitalopram, which are 2 x 10 mg
of the conventional dosage form (Treatment A) and 2 x 10 mg of the new dosage form being
tested (Treatment B) and 1 x 20 mg of the new dosage form being tested (Treatment C). Test
treatments B and C will each be compared to Treatment A, which is the active comparator
(reference formulation).
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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