NCT01566487

Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition

Randomized, Open-Label, Balanced, Two-treatment, Two-period, Two-sequence, Crossover, Multicentric Experimental Bioequivalence Study of Quetiapine Fumarate Film-coated Tablets 300 mg (Test)and Seroquel Film-coated Tablets 300 mg (Reference) Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study.

Detailed description

The objective of this study was to compare the bioavailability and characterise the pharmacokinetics profile of the sponsor formulation Quetiapine fumarate tablets 300 mg of Dr. Reddy's Laboratories Limited, India with respect to reference formulation Seroquel tablets 300 mg of Astrazeneca Pharmaceuticals, USA in adults schizophrenia patients under fasting condition. 54 subjects were dosed and were enrolled in the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Quetiapine fumarate	Quetiapine fumarate tablets 300mg

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2012-03-29
• Last updated: 2012-03-29

Locations

1 site across 1 country: India