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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
2 x 10 mg, single dose
2 x 10 mg, single dose
1 x 20 mg, single dose
NL001
Leiden, Netherlands
To show bioequivalence on the basis of the area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of two different dosage forms of escitalopram
The new dosage form being tested will be administered both as 2 x 10 mg and as 1 x 20 mg
Time frame: From the day of dosing up to 7 days in each dosing period
To investigate the safety and tolerability of the administration of the two dosage forms
Safety and tolerability parameters such as adverse advents, clinical safety laboratory tests and vital signs will be summarised using descriptive statistics
Time frame: Baseline + from the day of dosing up to 7 days in each dosing period
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