Clinical trial NCT01395433: Bioequivalence Study Comparing Two Formulations of Escitalopram
Official title: A Single-dose, Open-label, Randomised, Crossover Bioequivalence Study in Healthy Young Men Comparing Two Formulations of Escitalopram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Assessing the bioequivalence of escitalopram dosage forms
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From the day of dosing up to 7 days in each dosing period
Secondary outcomes:
measure: To investigate the safety and tolerability of the administration of the two dosage forms
timeFrame: Baseline + from the day of dosing up to 7 days in each dosing period
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: NL001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Nilausen DO, Zuiker RG, van Gerven J. The perception and pharmacokinetics of a 20-mg dose of escitalopram orodispersible tablets in a relative bioavailability study in healthy men. Clin Ther. 2011 Oct;33(10):1492-502. doi: 10.1016/j.clinthera.2011.09.012. Epub 2011 Oct 13.