Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions

Overview

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.

Full Title of Study: “A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2007

Interventions

  • Drug: Quetiapine Fumarate
    • 25 mg tablet

Clinical Trial Outcome Measures

Primary Measures

  • bioequivalence determined by statistical comparison Cmax
    • Time Frame: 15 days

Participating in This Clinical Trial

Inclusion Criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C. – Treatment with known enzyme altering drugs. – History of allergic or adverse response to quetiapine or any comparable or similar product.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Roxane Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor

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