Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition
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|ClinicalTrials.gov Identifier: NCT01722201|
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : November 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fasting||Drug: Risperidone Tablet 1 mg Drug: Risperidone||Phase 1|
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 fasting 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Fasting Condition|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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®
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 3 months ]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, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722201
|Accutest Research Lab (I) Pvt. Ltd.|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Tarang Shah, M.D.||Accutest Research Lab (I) Pvt. Ltd.|