Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648193
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Healthy
Drug: Paroxetine hydrochloride 40 mg tablet
Drug: Paxil® 40 mg Table
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single-Dose Fasting Bioequivalence Study of Paroxetine Hydrochloride Tablets (40 mg; Mylan) and Paxil® Tablets (40 mg; GSK) in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2006
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18 years and older.
  2. Sex: Male and/or female of non-childbearing potential.

    1. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:

      1. postmenopausal with an absence of menses for at least one (1) year, or
      2. bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
      3. total hysterectomy and an absence of bleeding for at least three months
    2. 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.
  3. 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).
  4. 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:

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

    1. Use of any tobacco-containing products within 1 year of the start of the study.
    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.
    5. A positive test for any drug included in the urine drug screen.
    6. History of drug and/or alcohol abuse.
  3. Medications:

    1. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
    2. Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing.
    3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
    4. Use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine within 30 days prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
    2. Acute illness at the time of either the pre-study medical evaluation or dosing.
    3. A positive HIV, Hepatitis B, or Hepatitis C test.
  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 paroxetine or any related products.
  9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
  11. History of depression, mania, seizure, akathisia, narrow angle glaucoma, and/or suicidal ideation or behavior (suicidality).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648193

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Bruce T Czarnik, M.D. Cetero Research, San Antonio
  More Information

Additional Information:
No publications provided

Responsible Party: Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00648193     History of Changes
Other Study ID Numbers: PARO-0678
Study First Received: March 30, 2008
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014