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Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition

NCT01578265 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-04-16

No results posted yet for this study

Summary

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over 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.

Conditions

  • Fed

Interventions

DRUG

Ondansetron Tablets USP 8 mg

8 mg tablet once a day

DRUG

Ondansetron Hydrochloride

8 mg tablet once a day

Sponsors & Collaborators

  • IPCA Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Tarang Shah, M.D. · Accutest Research Lab (I) Pvt. Ltd.

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
2011-05-31
Primary Completion
2011-09-30
Completion
2011-09-30

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 NCT01578265 on ClinicalTrials.gov