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Risperidone 1 mg Tablet in Healthy Subjects Under Fasting Conditions

NCT00830349 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-19

No results posted yet for this study

Summary

The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablet under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Risperidone

1 mg Tablet

DRUG

Risperidone

1 mg Tablets

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Benoit Girard, MD · Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2001-07-31
Completion
2004-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00830349 on ClinicalTrials.gov