An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of Aventis, in Healthy Subjects Under Fasting Conditions

Dr. Reddy's Laboratories Limited1 site in 1 country54 target enrollmentFebruary 2007

ConditionsHealthy

InterventionsFexofenadine HCl + Pseudoephedrine HCl

DrugsFexofenadine HCl + Pseudoephedrine HCl

Overview

Phase: Phase 1
Intervention: Fexofenadine HCl + Pseudoephedrine HCl
Conditions: Healthy
Sponsor: Dr. Reddy's Laboratories Limited
Enrollment: 54
Locations: 1
Primary Endpoint: Bioequivalence based on Cmax and AUC parameters
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to

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.
Monitor the adverse events and ensure the safety of subjects.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

April 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Dr. Reddy's Laboratories Limited

Eligibility Criteria

Inclusion Criteria

•Human subjects aged between 18 and 45 years (including both)
•Subjects'weight within the normal range according to normal values for the Body Mass Index (18.5 to 24.9kgm2)with minimum of 50 kg weight.
•Subjects with normal health as determined by personal medical history clinical examination and laboratory examinations within the clinically acceptable normal range.
•Subjects having normal 12-lead electrocardiogram (ECG).
•Subjects having normal chest X-Ray (P/A view).
•Have a negative urine screen for drugs of abuse (including amphetamines,barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
•Have negative alcohol breath test.
•Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria

•Subjects will be excluded from the study, if they meet any of the following criteria:
•Hypersensitivity to Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride or related drugs.
•History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
•History or presence of significant alcoholism or drug abuse in the past one year.
•History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
•History or presence of significant asthma, urticaria or other allergic reactions.
•History or presence of significant gastric and/or duodenal ulceration.
•History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
•History or presence of cancer.
•Difficulty with donating blood.