Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fasting Condition
|ClinicalTrials.gov Identifier: NCT01603173|
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fasting State||Drug: Quetiapine Fumarate Tablets 25 mg Drug: Quetiapine Fumarate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Fasting Condition|
|Study Start Date :||April 2011|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2011|
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®
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 8 months ]Area Under Curve (AUC)and Cmax Sampling Hours: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603173
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Nirav Gandhi, M.D.||Accutest Research Lab (I) Pvt. Ltd.|