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Bioequivalence Test for Risperdal 2mg of Janssen Korea

NCT02012049 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-12-16

No results posted yet for this study

Summary

The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.

Conditions

  • Healthy

Interventions

DRUG

Risperdal OD Tab. 2mg

1 tablet Risperdal OD 2 mg administered orally.

DRUG

Risperdal Quicklet Tab. 2mg

1 tablet Risperdal Quicklet Tab. 2mg administered orally.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd., Korea Clinical Trial · Janssen Korea, Ltd., Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

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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 NCT02012049 on ClinicalTrials.gov