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Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Fexofenadine HCl + Pseudoephedrine HCl (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Dr. Dharmesh Domadia, Principal Investigator, Affiliation: Veeda Clinical Research Pvt. Ltd.,

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.

Clinical Details

Official title: 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 Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on Cmax and AUC parameters

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 fed conditions.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

- Difficulty in swallowing solids like tablets or capsules.

- Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.

- Diastolic blood pressure less than SO mm Hg or more than 90 mm Hg.

- Pulse rate less than 50/minute or more than 100/minute.

- Oral temperature less than 95°F or more than 98. 5°F.

- Respiratory rate less than 12/minute or more than 20/minute

- SUbjects who have used any prescription medication, within 14 days of period 01

dosing or OTC medication within 14 days of period 01 dosing.

- Major illness during 3 months before screening.

- Participation in a drug research study within past 3 months.

- Donation of blood in the past 3 months before screening.

- Subjects who have consumed xanthine-containing products (including caffeine,

theobromines, etc.) within 48 hours prior to period 01 dosing.

- Subjects who have consumed food or beverages containing grapefruit or pomelo within

14 days prior to period 01 dosing.

Locations and Contacts

Veeda Clinical Research Pvt. Ltd.,, Ahmedabad, Gujrat 380015, India
Additional Information

Starting date: April 2007
Last updated: June 11, 2010

Page last updated: August 23, 2015

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