A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Fasting Conditions

NCT00864344 | Completed Phase 1

• 1 other identifier: 20-682-1G
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. administrated to healthy subjects after a 10-ghour overnight fast

Conditions

Healthy

Keywords

Bioequivalence; Sertralin; Healthy subjectse

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  96 hours

Study Arms (2)

A

EXPERIMENTAL

Sertraline HCl 100 mg tablets, single dose

Drug: Sertraline HCl 100 mg tablets, single dose

B

ACTIVE COMPARATOR

Zoloft® 100 mg tablets, single dose

Drug: Zoloft® 100 mg tablets, single dose

Interventions

Sertraline HCl 100 mg tablets, single dose DRUG

A: Experimental SSubjects received Purepac formulated products under fasting conditions

Also known as: Sertraline

A

Zoloft® 100 mg tablets, single dose DRUG

B: Active comparator Subjects received Pfizer formulated products under fasting conditions

Also known as: Sertraline

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

CEDRA Clinical Research, LLC

Austin, Texas, 78759, United States

Location

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Daniel V. Freeland,, D.O., CCI

  CEDRA Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: August 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

US (1)