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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fexofenadine HCl + Pseudoephedrine HCl

• Registration Number: NCT01133483
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief 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.

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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-04
• Study Completion: 2007-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-11
• Last Update Posted: 2010-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fexofenadine HCl + Pseudoephedrine HCl	Fexofenadine HCl + Pseudoephedrine HCl	Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories
Allegra-D 24 hour ER Tablets	Fexofenadine HCl + Pseudoephedrine HCl	Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA.

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC parameters	2 months

Trial Locations

Locations (1)

Veeda Clinical Research Pvt. Ltd.,; 🇮🇳 Ahmedabad, Gujrat, India