Bioequivalence Study Comparing Two Formulations of Escitalopram

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395433

13154A

2009-015108-24 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Treatment A

Active Comparator group

Description:

Conventional escitalopram

Treatment:

Drug: Escitalopram

Drug: Escitalopram

Drug: Escitalopram

Treatment B

Experimental group

Description:

Escitalopram test treatment B

Treatment:

Drug: Escitalopram

Drug: Escitalopram

Drug: Escitalopram

Treatment C

Experimental group

Description:

Escitalopram test treatment C

Treatment:

Drug: Escitalopram

Drug: Escitalopram

Drug: Escitalopram