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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01133483
First received: May 27, 2010
Last updated: June 11, 2010
Last verified: June 2010

May 27, 2010
June 11, 2010
April 2007
April 2007   (final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01133483 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
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

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 fed conditions.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Fexofenadine HCl + Pseudoephedrine HCl
Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories Limited
Other Name: Allegra-D 24 hour ER Tablets
  • Experimental: Fexofenadine HCl + Pseudoephedrine HCl
    Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories
    Intervention: Drug: Fexofenadine HCl + Pseudoephedrine HCl
  • Active Comparator: Allegra-D 24 hour ER Tablets
    Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA.
    Intervention: Drug: Fexofenadine HCl + Pseudoephedrine HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
May 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01133483
07-VIN-057
Yes
Mr. Indu Bhushan / Senior Director, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Dr. Dharmesh Domadia Veeda Clinical Research Pvt. Ltd.,
Dr. Reddy's Laboratories Limited
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP