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Bioequivalence Study Comparing Two Formulations of Escitalopram

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01395433
First received: July 13, 2011
Last updated: December 7, 2012
Last verified: December 2012
History of Changes

July 13, 2011
December 7, 2012
January 2010
March 2010   (final data collection date for primary outcome 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 [ Time Frame: From the day of dosing up to 7 days in each dosing period ] [ Designated as safety issue: No ]
The new dosage form being tested will be administered both as 2 x 10 mg and as 1 x 20 mg
Same as current
Complete list of historical versions of study NCT01395433 on ClinicalTrials.gov Archive Site
To investigate the safety and tolerability of the administration of the two dosage forms [ Time Frame: Baseline + from the day of dosing up to 7 days in each dosing period ] [ Designated as safety issue: Yes ]
Safety and tolerability parameters such as adverse advents, clinical safety laboratory tests and vital signs will be summarised using descriptive statistics
Same as current
Not Provided
Not Provided
 
Bioequivalence Study Comparing Two Formulations of Escitalopram
A Single-dose, Open-label, Randomised, Crossover Bioequivalence Study in Healthy Young Men Comparing Two Formulations of Escitalopram

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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Escitalopram
    2 x 10 mg, single dose
  • Drug: Escitalopram
    1 x 20 mg, single dose
  • Active Comparator: Treatment A
    Conventional escitalopram
    Intervention: Drug: Escitalopram
  • Experimental: Treatment B
    Escitalopram test treatment B
    Intervention: Drug: Escitalopram
  • Experimental: Treatment C
    Escitalopram test treatment C
    Intervention: Drug: Escitalopram
Nilausen DØ, 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. Epub 2011 Oct 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
March 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01395433
13154A, 2009-015108-24
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP