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Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition

NCT01888718 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-06-28

No results posted yet for this study

Summary

To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U.S. LLC, Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To monitor adverse events and ensure the safety of subjects.

Conditions

  • Healthy

Interventions

DRUG

Fexofenadine Hydrochloride

Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Vimal Teja, MD · Bioserve Clinical Research Private Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-02-28
Completion
2011-03-31

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 NCT01888718 on ClinicalTrials.gov