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Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions

NCT01133470 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2010-06-14

No results posted yet for this study

Summary

The purpose of this study is to

1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.
2. Monitor the adverse events and ensure the safety of subjects.

Conditions

  • Healthy

Interventions

DRUG

Fexofenadine HCl + Pseudoephedrine HCl

Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's KLaboratories Limited

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Dharmesh Domadia · Veeda Clinical Research 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
2007-02-28
Primary Completion
2007-02-28
Completion
2007-04-30

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 NCT01133470 on ClinicalTrials.gov