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Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition

Sponsor
Dr. Reddy's Laboratories Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT01506050
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
1
Duration (Months)
34.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
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
Study Start Date :
Jan 1, 2006
Actual Study Completion Date :
Feb 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Desloratadine OD tablets 5 mg

Desloratadine OD tablets 5 mg of Dr. Reddy's Laboratories Limited

Drug: Desloratadine
Desloratadine ODT 5 mg
Other Names:
  • Clarinex ODT 5 mg

    		•
    Active Comparator: Clarinex

    Clarinex 5 mg of Schering Corporation Inc USA

    Drug: Desloratadine
    Desloratadine ODT 5 mg
    Other Names:
  • Clarinex ODT 5 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under curve(AUC) [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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Reddy's Laboratories Limited
    ClinicalTrials.gov Identifier:
    NCT01506050
    Other Study ID Numbers:
    • 50632
    First Posted:
    Jan 9, 2012
    Last Update Posted:
    Jan 9, 2012
    Last Verified:
    May 1, 2006
    Keywords provided by Dr. Reddy's Laboratories Limited
    Bioequivalence
    Desloratadine
    crossover
    Additional relevant MeSH terms:
    Desloratadine

    Study Results

    No Results Posted as of Jan 9, 2012