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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01133470
First received: May 27, 2010
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

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.

Condition Intervention Phase
Healthy
Drug: Fexofenadine HCl + Pseudoephedrine HCl
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2007
Study Completion Date: April 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fexofenadine HCl + Pseudoephedrine HCl
Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories
Drug: Fexofenadine HCl + Pseudoephedrine HCl
Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's KLaboratories Limited
Other Name: Allegra-D 24 hour ER Tablets
Active Comparator: Allegra-D 24 hour ER Tablets
Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA.
Drug: Fexofenadine HCl + Pseudoephedrine HCl
Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's KLaboratories Limited
Other Name: Allegra-D 24 hour ER Tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133470

Locations
India
Veeda Clinical Research Pvt. Ltd.,
Ahmedabad, Gujrat, India, 380015
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Dharmesh Domadia Veeda Clinical Research Pvt. Ltd.,
  More Information

No publications provided

Responsible Party: Mr. Indu Bhushan / Senior Director, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01133470     History of Changes
Other Study ID Numbers: 07-VIN-029
Study First Received: May 27, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Fexofenadine Hydrochloride + Pseudoephedrine Hydrochloride

Additional relevant MeSH terms:
Pseudoephedrine
Ephedrine
Fexofenadine
Terfenadine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on July 28, 2014