Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions.

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01314339
First received: March 11, 2011
Last updated: February 17, 2012
Last verified: September 2005
  Purpose

The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting conditions.


Condition Intervention Phase
Fasting
Drug: Desloratadine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet 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:
  • Bioavailability is based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2005
Study Completion Date: February 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desloratadine Tablets, 5 mg
Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories
Drug: Desloratadine
Desloratadine Tablets, 5 mg
Other Name: Clarinex® 5 mg
Active Comparator: Clarinex
Clarinex® 5 mg Tablets of Schering-Plough
Drug: Desloratadine
Desloratadine Tablets, 5 mg
Other Name: Clarinex® 5 mg

Detailed Description:

A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Fasted Normal,Healthy subjects.

  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 and women who volunteers to participate?
  • Is s/he within 18 and 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 weeks 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?

A no answer to any of the above questions indicates that the individual is ineligible for enrollment

Exclusion Criteria:

Does the individual have a history of allergy or hypersensitivity to desloratadine?

  • 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 diseases 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-1, 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 used any tobacco products in the 3 months preceding drug administration?
  • Has s/he received an investigational drug during the 30 day period preceding study initiation? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314339

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

No publications provided

Responsible Party: Dr. M.S. Mohan, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01314339     History of Changes
Other Study ID Numbers: 50485
Study First Received: March 11, 2011
Last Updated: February 17, 2012
Health Authority: United States: Food and Drug Administration

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 23, 2014