NCT01395433

Bioequivalence Study Comparing Two Formulations of Escitalopram

A Single-dose, Open-label, Randomised, Crossover Bioequivalence Study in Healthy Young Men Comparing Two Formulations of Escitalopram

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Escitalopram	2 x 10 mg, single dose
DRUG	Escitalopram	2 x 10 mg, single dose
DRUG	Escitalopram	1 x 20 mg, single dose

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-03-01
• First posted: 2011-07-15
• Last updated: 2012-12-10

Locations

1 site across 1 country: Netherlands