Status:
COMPLETED
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.
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), deslorata...
Eligibility Criteria
Inclusion
- 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
- 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?
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01506050
Start Date
January 1 2006
End Date
February 1 2006
Last Update
January 9 2012
Active Locations (1)
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1
SFBC Ft Myers Inc
Broadway, Florida, United States, 33901