Bioequivalence Study Comparing Two Formulations of Escitalopram

NCT01395433 | Completed Phase 1

• 2 other identifiers: 13154A2009-015108-24
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Assessing the bioequivalence of escitalopram dosage forms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To investigate the safety and tolerability of the administration of the two dosage forms

  Baseline + from the day of dosing up to 7 days in each dosing period

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

Conventional escitalopram

Drug: Escitalopram

Treatment B

EXPERIMENTAL

Escitalopram test treatment B

Drug: Escitalopram

Treatment C

EXPERIMENTAL

Escitalopram test treatment C

Drug: Escitalopram

Interventions

Escitalopram DRUG

2 x 10 mg, single dose

Treatment A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

NL001

Leiden, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 21999886 RESULT

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

NL (1)