Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01506791
First received: September 27, 2011
Last updated: January 5, 2012
Last verified: June 2006
  Purpose

This is an open label, randomised, 2-way crossover, comparative bioequivalence study.


Condition Intervention Phase
Healthy
Drug: Desloratadine and pseudoephedrine
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: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fed Conditions

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under curve(AUC) [ Time Frame: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: April 2006
Study Completion Date: April 2006
Arms Assigned Interventions
Experimental: Desloratadine and pseudoephedrine ER tablets 5/240 mg
Desloratadine and pseudoephedrine ER tablets 5/240 mg of Dr. Reddy's Laboratories Limited
Drug: Desloratadine and pseudoephedrine
Desloratadine and pseudoephedrine 5/240 mg
Other Name: Clarinex D-24
Active Comparator: Clarinex D 24-hour
Clarinex D-24 of Schering Corporation Inc USA
Drug: Desloratadine and pseudoephedrine
Desloratadine and pseudoephedrine 5/240 mg
Other Name: Clarinex D-24

Detailed Description:

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation, U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg extended-release tablet under fed conditions. The treatment phases were separated by a washout period of 14 days. 44 subjects were dosed and were enrolled in the study; 43 of these enrolled subjects completed the study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is the individual a healthy, normal adult man or woman who volunteers to participate?
  • Is s/he within 18 to 45 years of age, inclusive?
  • Is his/her BMI between 19 and 30 inclusive?
  • Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study?
  • Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
  • Has s/he provided written informed consent?

Exclusion Criteria:

  • Does the individual have a history or allergy or hypersensitivity to desloratadine or pseudoephedrine, milk or eggs?
  • Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
  • Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
  • Is she nursing?
  • Does s/he have serious psychological illness?
  • Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
  • Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test?
  • Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
  • Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation?
  • Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
  • Has s/he donated or lost blood or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
  • Has s/he donated plasma during the two week period preceding study initiation?
  • Has s/he received an investigational drug during the 30 day period preceding study initiated?
  • Has s/he used any tobacco products in the 3 months preceding drug administration?
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506791

Locations
United States, Florida
SFBC Ft Myers Inc
Broadway, Florida, United States, 33901
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Antonio R Pizarro, MD SFBC Anapharm
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01506791     History of Changes
Other Study ID Numbers: 50631
Study First Received: September 27, 2011
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Desloratadine and pseudoephedrine
crossover

Additional relevant MeSH terms:
Pseudoephedrine
Ephedrine
Desloratadine
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
Cholinergic Antagonists
Cholinergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on April 17, 2014