- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506050
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition
January 6, 2012 updated by: Dr. Reddy's Laboratories Limited
Randomized, Single Dose, 2-Way Crossover, Relative Bioavailability Study of Desloratadine Orally Disintegrating Tablet Fasting Conditions
This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.
Study Overview
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Broadway, Florida, United States, 33901
- SFBC Ft Myers Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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?
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Desloratadine OD tablets 5 mg
Desloratadine OD tablets 5 mg of Dr. Reddy's Laboratories Limited
|
Desloratadine ODT 5 mg
Other Names:
|
Active Comparator: Clarinex
Clarinex 5 mg of Schering Corporation Inc USA
|
Desloratadine ODT 5 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antonio R Pizarro, MD, SFBC Anapharm
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
January 5, 2012
First Submitted That Met QC Criteria
January 6, 2012
First Posted (Estimate)
January 9, 2012
Study Record Updates
Last Update Posted (Estimate)
January 9, 2012
Last Update Submitted That Met QC Criteria
January 6, 2012
Last Verified
May 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50632
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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