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

Roxane Laboratories42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar I Disorder

Interventions

Quetiapine FumarateDRUG

25 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Novum Pharmaceutical Research Services

Houston, Texas, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 15 days

Data from ClinicalTrials.gov

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