Bioequivalence Study Comparing Two Formulations of Escitalopram

Study Overview
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Brief Summary
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Escitalopram
* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 19 kg/m2 and 29 kg/m2, inclusive The subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests Exclusion Criteria: The subject has taken disallowed medication within 1 week prior to the first dose of investigational medicinal product (IMP), or within 5 half-lives prior to inclusion for any medication ingested, whichever is longer The subject has a significant history of drug or alcohol abuse The subject has taken any investigational products within 3 months prior to the first dose of IMP The subject has a history of or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of IMP The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or nonperipheral vascular surgery within 6 months prior to the first dose of IMP The subject has any concurrent illness that may affect the particular target or metabolism of the IMP The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Conventional escitalopram | Drug: Escitalopram<br>* 2 x 10 mg, single dose<br>|
| Experimental: Treatment B<br>Escitalopram test treatment B | Drug: Escitalopram<br>* 2 x 10 mg, single dose<br>|
| Experimental: Treatment C<br>Escitalopram test treatment C | Drug: Escitalopram<br>* 1 x 20 mg, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From the day of dosing up to 7 days in each dosing period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline + from the day of dosing up to 7 days in each dosing period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assessing the bioequivalence of escitalopram dosage forms