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Clinical Trials/NCT00830349
NCT00830349CompletedPhase 1

Randomized, 2-Way Crossover, Bioequivalence Study of Risperidone 1 mg Tablets and Risperdal 1 mg Tablets Administered as a 1 x 1 mg Tablet in Healthy Subjects Under Fasting Conditions

Teva Pharmaceuticals USA1 site in 1 country30 target enrollmentStarted: June 2001Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Bioequivalence based on Cmax and AUC
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

2

Active Comparator

Risperdal® 1 mg Tablets

Intervention: Risperidone (Drug)

1

Experimental

Risperidone 1 mg Tablets

Intervention: Risperidone (Drug)

Outcomes

Primary Outcomes

Bioequivalence based on Cmax and AUC

Time Frame: 2 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (1)

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