Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01506037
First received: January 5, 2012
Last updated: January 10, 2012
Last verified: May 2006
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Desloratadine
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, Single Dose, 2-Way Crossover, Relative Bioavailability Study of Desloratadine Orally Disintegrating Tablet 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 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120 and 144 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2006
Study Completion Date: February 2006
Arms Assigned Interventions
Experimental: Desloratadine OD tablets 5 mg
Desloratadine OD tablets 5 mg of Dr. Reddy's Laboratories Limited
Drug: Desloratadine
Desloratadine ODT 5 mg
Other Name: Clarinex ODT 5 mg
Active Comparator: Clarinex
Clarinex 5 mg of Schering Corporation Inc USA
Drug: Desloratadine
Desloratadine ODT 5 mg
Other Name: Clarinex ODT 5 mg

Detailed Description:

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine ODT 5 mg and Schering Corporation, U.S.A.(Clarinex® 5 mg), desloratadine ODT 5 mg under fed conditions. The treatment phases were separated by a washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 36 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, 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: NCT01506037

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: NCT01506037     History of Changes
Other Study ID Numbers: 50633
Study First Received: January 5, 2012
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on April 22, 2014