A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864019
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

To compare the rate of absorption and oral bioavailability of a test formulation of Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to each dose.


Condition Intervention Phase
Healthy
Drug: Sertraline HCl 100 mg tablets, single dose
Drug: Zoloft® 100 mg tablets, single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Sertraline 100 mg Tablets Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 96 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Sertraline HCl 100 mg tablets, single dose
Drug: Sertraline HCl 100 mg tablets, single dose
A: Experimental SSubjects received Purepac formulated products under non-fasting conditions
Other Name: Sertraline
Active Comparator: B
Zoloft® 100 mg tablets, single dose
Drug: Zoloft® 100 mg tablets, single dose
B: Active comparator Subjects received Pfizer formulated products under non-fasting conditions
Other Name: Sertraline

Detailed Description:

Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period crossover study

Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Sertraline 100 mg Tablets Under Fed Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be a male or non-pregnant, non-breast-feeding female.
  • Subject must be between 18 and 55 years of age inclusive.
  • Subject's body weight should be within ±15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table.
  • Female subjects --- not surgically sterile or at least two years postmenopausal --- must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
  • Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return to the study site for all out-patient visits.

Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Has a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.
  • History or presence of allergic or adverse response to the study drug or related drugs.
  • Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
  • Has donated blood or plasma within 30 days prior to the first dose of study medication.
  • Has participated in another clinical trial within 30 days prior to first dose of study medication.
  • Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication.
  • Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication.
  • Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
  • Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
  • Female with a positive pregnancy test.
  • Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
  • Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.
  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: NCT00864019

Locations
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Daniel V. Freeland,, D.O., CCI CEDRA Clinical Research, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864019     History of Changes
Other Study ID Numbers: 20-683-1G
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Sertraline
Healthy subjects

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

ClinicalTrials.gov processed this record on August 28, 2014