Status:
COMPLETED
Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 adminis...
Eligibility Criteria
Inclusion
- Age: 18 years and older.
- Sex: Male and/or female of non-childbearing potential.
- Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- postmenopausal with an absence of menses for at least one (1) year, or
- bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- total hysterectomy and an absence of bleeding for at least three months
- 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.
- 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).
- 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
- Institutionalized subjects will not be used.
- Social Habits:
- Use of any tobacco-containing products within 1 year of the start of the study.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
- A positive test for any drug included in the urine drug screen.
- History of drug and/or alcohol abuse.
- Medications:
- Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
- Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine within 30 days prior to the initial dose of study medication.
- Diseases:
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- A positive HIV, Hepatitis B, or Hepatitis C test.
- Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to paroxetine or any related products.
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
- History of depression, mania, seizure, akathisia, narrow angle glaucoma, and/or suicidal ideation or behavior (suicidality).
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00648193
Start Date
December 1 2006
End Date
January 1 2007
Last Update
April 24 2024
Active Locations (1)
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1
Gateway Medical Research, Inc.
Saint Charles, Missouri, United States, 63301