Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fasting Conditions

NCT00779350 | Completed DMC

• 1 other identifier: 10540323
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the relative bioavailability of the test formulation of sertraline 100 mg tablets with an already marketed reference formulation Zoloft® 100 mg tablets (Pfizer), under fasted conditions in healthy male and female adult subjects.

Conditions

Healthy

Keywords

Bioequivalence sertraline 100 mg tablets fasting conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

sertraline 100 mg tablets of ranbaxy

Drug: sertraline 100 mg tablets

2

ACTIVE COMPARATOR

Zoloft® 100 mg tablets

Drug: sertraline 100 mg tablets

Interventions

sertraline 100 mg tablets DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• Males and females, 18-65 years of age (inclusive).
• A body mass index (BMI) of 18-30 kg/m2 inclusive as measured and calculated according to Novum Standard Operating Procedures.
• Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
• Signed and dated informed consent form, which meets all criteria of current FDA regulations.
• Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.

You may not qualify if:

• If female, pregnant, lactating or likely to become pregnant during the study.
• History of allergy or sensitivity to sertraline hydrochloride or other selective serotonin reuptake inhibitor's (SSRI's), or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
• Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
• Presence of gastrointestinal disease or history of malabsorption within the last year.
• History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
• Presence of a medical condition requiring regular treatment with prescription drugs.
• Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
• Use within 14 days of dosing, or anticipated use during the study, or for 14 days after the last dose of sertraline any monoamine oxidase inhibitors (MAOIs).
• Receipt of any drug as part of a research study within 30 days prior to dosing.
• Drug or alcohol addiction requiring treatment in the past 12 months.
• Donation or significant loss of whole blood (480 ml or more) with/n 30 days or plasma within 14 days prior to dosing.
• Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
• Positive test results for drugs of abuse at screening.
• Positive serum pregnancy test.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Links

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MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: August 1, 2005
• Primary Completion: August 1, 2005
• Study Completion: October 1, 2005
• Last Updated: October 24, 2008

Record last verified: 2008-10

Locations

US (1)