We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506050
First Posted: January 9, 2012
Last Update Posted: January 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Single Dose, 2-Way Crossover, Relative Bioavailability Study of Desloratadine Orally Disintegrating Tablet Fasting 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 ]

Enrollment: 35
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 fasting conditions. The treatment phases were separated by a washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 35 of these enrolled subjects completed the study.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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?
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506050


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

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01506050     History of Changes
Other Study ID Numbers: 50632
First Submitted: January 5, 2012
First Posted: January 9, 2012
Last Update Posted: January 9, 2012
Last Verified: May 2006

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

Additional relevant MeSH terms:
Desloratadine
Loratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Antipruritics
Dermatologic Agents
Anti-Allergic Agents