Sertraline Hydrochloride 100 mg Tablets, Fasting

NCT00836849 | Completed Phase 1

• 1 other identifier: 02070
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the rate and extent of absorption of sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg tablet under fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC

  3 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Sertraline hydrochloride 100 mg Tablets

2

ACTIVE COMPARATOR

Drug: Zoloft® 100 mg Tablets

Interventions

Zoloft® 100 mg Tablets DRUG

1 x 100 mg, single-dose fed

2

Sertraline hydrochloride 100 mg Tablets DRUG

1 x 100 mg, single-dose fed

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be females and/or males, non-smokers, 18 years of age and older. Female subjects will be post-menopausal or surgically sterilized.
• Post-menopausal status is defined as absence of menses for the past 12 months.
• Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

You may not qualify if:

• Clinically significant illnesses within 4 weeks of the administration of study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the medical sub-investigator, would preven the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive urine drug screen at screening
• Positive testing for hepatitis B, hepatitis C or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHG, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
• Subjects with BMI ≥ 30.0.
• History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%)
• History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
• History of allergic reactions to sertraline or other related drugs (e.g. fluoxetine hydrochloride, fluvoxamine hydrochloride, paroxetine hydrochloride).
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
• Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement and products containing dextromethorphan) within 7 days prior to administration of study medication, except for topical products without systemic absorption.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, GIV2K8, Canada

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

• Benoit Girard, M.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: March 1, 2002
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CA (1)