We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Study Comparing Two Formulations of Escitalopram

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395433
First Posted: July 15, 2011
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lundbeck A/S
  Purpose

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).


Condition Intervention Phase
Healthy Drug: Escitalopram Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-dose, Open-label, Randomised, Crossover Bioequivalence Study in Healthy Young Men Comparing Two Formulations of Escitalopram

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • 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 ]
    The new dosage form being tested will be administered both as 2 x 10 mg and as 1 x 20 mg


Secondary Outcome Measures:
  • 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 ]
    Safety and tolerability parameters such as adverse advents, clinical safety laboratory tests and vital signs will be summarised using descriptive statistics


Enrollment: 32
Study Start Date: January 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A
Conventional escitalopram
Drug: Escitalopram
2 x 10 mg, single dose
Experimental: Treatment B
Escitalopram test treatment B
Drug: Escitalopram
2 x 10 mg, single dose
Experimental: Treatment C
Escitalopram test treatment C
Drug: Escitalopram
1 x 20 mg, single dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395433


Locations
Netherlands
NL001
Leiden, Netherlands
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Publications:
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01395433     History of Changes
Other Study ID Numbers: 13154A
2009-015108-24 ( EudraCT Number )
First Submitted: July 13, 2011
First Posted: July 15, 2011
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by H. Lundbeck A/S:
Assessing the bioequivalence of escitalopram dosage forms

Additional relevant MeSH terms:
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents