Fasting Study of Escitalopram Oxalate Tablets 20 mg and Lexapro® Tablets 20 mg

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2004-10-31

Brief Summary

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The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administered under fasting conditions.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Escitalopram Oxalate Tablets 20 mg

Group Type EXPERIMENTAL

Escitalopram Oxalate Tablets 20 mg

Intervention Type DRUG

20mg, single dose fasting

2

Lexapro® Tablets 20 mg

Group Type ACTIVE_COMPARATOR

Lexapro® Tablets (20 mg

Intervention Type DRUG

20mg, single dose fasting

Interventions

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Escitalopram Oxalate Tablets 20 mg

20mg, single dose fasting

Intervention Type DRUG

Lexapro® Tablets (20 mg

20mg, single dose fasting

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 years and older.
2. Sex: Male and/or non-pregnant, non-lactating female

1. Women of childbearing potential must have negative serum β-human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, serum samples for β-HCG testing may be collected and sent for analysis within 48 hours prior to dosing for both study periods. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study.
2. Women of childbearing potential must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following:

1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
2. barrier methods containing or used in conjunction with a spermicidal agent, or
3. surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
3. Weight: At least 60 kg (132 lbs.) for men and 48 kg (106 lbs.) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-Lead ECG, Hepatitis B, Hepatitis C and HIV tests, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, methadone, and phencyclidine) performed within 14 days of the initial dose of study medication.

Exclusion Criteria

1. Institutionalized subjects will not be used.
2. Social Habits:

1. Use of any tobacco products within one year prior to dosing.
2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
4. Any recent, significant change in dietary or exercise habits.
3. Medications:

1. Use of any medication within the last 14 days prior to the initial dose of study medication, including over-the-counter medications.
2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
3. Use of hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication.
4. Due to potentially serious interaction with Monoamine Oxidase Inhibitors (MAOI), use of MAOI within 14 days prior to escitalopram dosing to 14 days after study completion is disallowed.
4. Diseases:

1. History of any significant chronic disease and/or hepatitis.
2. History of drug and/or alcohol abuse.
3. Acute illness at the time of either the pre-study medical evaluation or dosing.
4. A positive HIV, Hepatitis B, or Hepatitis C test result.
5. Abnormal and clinically significant laboratory test results:

1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
2. Abnormal and clinically relevant ECG tracing.
6. Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
8. Allergy or hypersensitivity to citalopram, any of the inactive ingredients or other related products.
9. History of difficulties in swallowing, or any gastrointestinal disease which could affect drug absorption.
10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes