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Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

NCT01511705 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-01-19

No results posted yet for this study

Summary

This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.

Conditions

  • Healthy

Interventions

DRUG

Ondansetron Hydrochloride

Ondansetron Hydrochloride Tablets 8 mg

DRUG

Ondansetron Hydrochloride

Zofran Tablets 8 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. I.S Gandhi · Vimta Labs Limited

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
2006-10-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • India

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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 NCT01511705 on ClinicalTrials.gov