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

NCT00648193 | Completed Early Phase 1

• 1 other identifier: PARO-0678
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

Paroxetine hydrochloride 40 mg tablet

Drug: Paroxetine hydrochloride 40 mg tablet

2

ACTIVE COMPARATOR

Paxil® 40 mg Table

Drug: Paxil® 40 mg Table

Interventions

Paroxetine hydrochloride 40 mg tablet DRUG

40mg, single dose fasting

1

Paxil® 40 mg Table DRUG

40mg, single dose fasting

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

Location

Related Links

• 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

MeSH Terms

Interventions

Paroxetine; Tablets

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Bruce T Czarnik, M.D.

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)