Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fed Condition
|Fed||Drug: Quetiapine Fumarate Tablets 25 mg Drug: Quetiapine Fumarate||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 Fed Condition|
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 8 months ]Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose.
|Study Start Date:||April 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Quetiapine Fumarate Tablets 25 mg
Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India
Drug: Quetiapine Fumarate Tablets 25 mg
25 mg tablet once a day
Other Name: Test Product
Active Comparator: Seroquel®
Seroquel® (Quetiapine Fumarate) Tablets 25 mg of M/s AstraZeneca Pharmaceuticals LP, USA
Drug: Quetiapine Fumarate
25 mg tablet once a day
Other Name: Seroquel®
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 fed 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603186
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Nirav Gandhi, M.D.||Accutest Research Lab (I) Pvt. Ltd.|