Overview

Bioequivalence Study Comparing Two Formulations of Escitalopram

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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).
Phase:
Phase 1
Details
Lead Sponsor:
H. Lundbeck A/S
Treatments:
Citalopram
Dexetimide