Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions

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?