Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
This is an open label, randomised, 2-way crossover, comparative bioequivalence study.
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's
 Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation,
 U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg
 extended-release tablet under fed conditions. The treatment phases were separated by a
 washout period of 14 days. 44 subjects were dosed and were enrolled in the study; 43 of these
 enrolled subjects completed the study.
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 or
 pseudoephedrine, milk or eggs?

 -  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?