Bioequivalence Study Comparing Two Formulations of Escitalopram

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395433
• Other study ID #: 13154A
• Secondary ID: 2009-015108-24
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2011
• Last updated: December 7, 2012
• Start date: January 2010

Study information

• Verified date: December 2012
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Escitalopram
2 x 10 mg, single dose
• Escitalopram
2 x 10 mg, single dose
• Escitalopram
1 x 20 mg, single dose

Locations

Country	Name	City	State
Netherlands	NL001	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. doi: 10.1016/j.clinthera.2011.09.012. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes