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.
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals Inc., USA in healthy, adult, human subjects under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's KLaboratories Limited
Veeda Clinical Research Pvt. Ltd.,
Ahmedabad, Gujarat, India
Bioequivalence based on Cmax and AUC parameters
Time frame: 3 months
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