NCT01603173

Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fasting Condition

A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.

Detailed description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Seroquel® (Quetiapine fumarate) Tablets 25 mg of M/s AstraZeneca Pharmaceuticals LP, USA, under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study. The study was conducted with 54 healthy adult subjects. In each study period, a single 25 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position. The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.

Conditions

• Fasting State

Interventions

Type	Name	Description
DRUG	Quetiapine Fumarate Tablets 25 mg	25 mg tablet once a day
DRUG	Quetiapine Fumarate	25 mg tablet once a day

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2012-05-22
• Last updated: 2012-05-22

Locations

1 site across 1 country: India