Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-04-16 @ 8:08 PM
Study NCT ID:
NCT01618760
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition
Sponsor:
IPCA Laboratories Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: