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

Roxane Laboratories

Status: Completed

Conditions: Treatment for Bipolar I Disorder

Treatments: Drug: Quetiapine Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01570907

QUET-T25-PVFS-2

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)