Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
Study Details
Study Description
Brief Summary
The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Paroxetine hydrochloride 40 mg tablet |
Drug: Paroxetine hydrochloride 40 mg tablet
40mg, single dose fasting
|
| Active Comparator: 2 Paxil® 40 mg Table |
Drug: Paxil® 40 mg Table
40mg, single dose fasting
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence [within 30 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18 years and older.
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Sex: Male and/or female of non-childbearing potential.
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Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
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postmenopausal with an absence of menses for at least one (1) year, or
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bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
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total hysterectomy and an absence of bleeding for at least three months
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During the course of the study, from study screen until study exit - including the washout period, all men must use a spermicide containing barrier method of contraception (i.e. a condom containing spermicide). This advice should be documented in the informed consent form.
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Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women with all subjects having a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19 (see Part II, Administrative Aspects of Bioequivalence Protocols).
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All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B and Hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.
Exclusion Criteria:
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Institutionalized subjects will not be used.
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Social Habits:
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Use of any tobacco-containing products within 1 year of the start of the study.
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Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
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Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
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Any recent, significant change in dietary or exercise habits.
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A positive test for any drug included in the urine drug screen.
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History of drug and/or alcohol abuse.
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Medications:
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Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
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Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing.
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Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
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Use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine within 30 days prior to the initial dose of study medication.
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Diseases:
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History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
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Acute illness at the time of either the pre-study medical evaluation or dosing.
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A positive HIV, Hepatitis B, or Hepatitis C test.
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Abnormal and clinically significant laboratory test results:
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Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
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Abnormal and clinically relevant ECG tracing.
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Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
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Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
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Allergy or hypersensitivity to paroxetine or any related products.
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History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
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Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
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History of depression, mania, seizure, akathisia, narrow angle glaucoma, and/or suicidal ideation or behavior (suicidality).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gateway Medical Research, Inc. | St. Charles | Missouri | United States | 63301 |
Sponsors and Collaborators
- Mylan Pharmaceuticals Inc
Investigators
- Principal Investigator: Bruce T Czarnik, M.D., Cetero Research, San Antonio
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Mylan Pharmaceuticals Inc. - Clinical Trial Results
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
- Recalls, Market Withdrawals and Safety Alerts
Publications
None provided.- PARO-0678