Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult human subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Risperidone Tablet 1 mg With Risperdal® 1 mg in Normal, Healthy, Adult, Human Subjects Under Fed Condition|
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 1 month ] [ Designated as safety issue: No ]Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 03.50, 03.75, 04.00, 05.00, 06.00, 08.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours post-dose.
|Study Start Date:||May 2012|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Risperidone Tablet 1 mg
Risperidone Tablet 1 mg of M/s Ipca Laboratories Limited, India
Drug: Risperidone Tablet 1 mg
1 mg tablet once a day
Other Name: Test Product
Active Comparator: Risperdal®
Risperdal® (Risperidone) Tablet 1 mg of Janssen Pharmaceutica Products, USA
1 mg tablet once a day
Other Name: Risperdal®
Objective of this pivotal study was to assess the bioequivalence between Test Product: Risperidone Tablet 1 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Risperdal® (Risperidone) Tablets 25 mg of Janssen Pharmaceutica Products, USA, under fed condition in normal, healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 1 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 16 days including washout period of at least 10 days between administrations of study drug in each study period.
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Tarang Shah, M.D.||Accutest Research Lab (I) Pvt. Ltd.|