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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
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ 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


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 ] [ 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


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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 13, 2011
Last Updated: December 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on May 19, 2013