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Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition

NCT01503437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-01-05

No results posted yet for this study

Summary

The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse events and ensure safety of subjects.

Conditions

  • Fasting

Interventions

DRUG

Olanzapine OD Tablets 5 mg

Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Ghanashyam Rao, MBBS · Wellquest Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2006-11-30
Completion
2006-12-31

Countries

  • India

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 NCT01503437 on ClinicalTrials.gov