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NCT01570894 Clinical Trial

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

Bipolar I Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01570894
Other study ID # QUET-T25-PVFD-2
Secondary ID
Status Completed
Phase N/A
First received March 28, 2012
Last updated January 19, 2018
Start date July 2007
Est. completion date July 2007

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Quetiapine Fumarate
25 mg tablet

Locations
Country Name City State
United States Novum Pharmaceutical Research Services Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary bioequivalence determined by statistical comparison Cmax 15 days
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