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OpenTrials
Completed

NCT Number: NCT01570894

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

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

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Key information

Conditions

Bipolar I Disorder

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novum Pharmaceutical Research Services

Houston, Texas, 77042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quetiapine fumarate

Drug

25 mg tablet

Other names: Seroquel

Primary outcomes

  1. bioequivalence determined by statistical comparison Cmax

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 4, 2012
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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