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

Completed · Not applicable

Conditions studied: Treatment for Bipolar I Disorder

In brief

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

Key facts

Study ID

NCT01570907

Run by

Roxane Laboratories

People needed

42

Starts

2007-06-01

Expected to finish

2007-07-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Novum Pharmaceutical Research Services — Houston, Texas, United States

Full record on ClinicalTrials.gov

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