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Bioequivalence Study Comparing Two Formulations of Escitalopram

NCT ID: NCT01395433

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy

Keywords

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Assessing the bioequivalence of escitalopram dosage forms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Conventional escitalopram

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

2 x 10 mg, single dose

Treatment B

Escitalopram test treatment B

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

2 x 10 mg, single dose

Treatment C

Escitalopram test treatment C

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

1 x 20 mg, single dose

Interventions

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Escitalopram

2 x 10 mg, single dose

Intervention Type DRUG

Escitalopram

2 x 10 mg, single dose

Intervention Type DRUG

Escitalopram

1 x 20 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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NL001

Leiden, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 21999886 (View on PubMed)

Other Identifiers

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2009-015108-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13154A

Identifier Type: -

Identifier Source: org_study_id