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
Completed
Dr. Reddy's Laboratories Limited
Phase 1
2007-02-01
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.
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
Completed
Dr. Reddy's Laboratories Limited
Phase 1
2007-04-01
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.
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Completed
Sanofi
Phase 3
2011-02-01
Primary Objective:
- To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg -
pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg -
pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60)
in patients with seasonal allergic rhinitis (SAR).
Secondary Objectives:
- To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on
nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily
activity impairment.
- To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.
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