bioavailability study of desloratadine 5 mg tablet of dr. reddy's under fed conditions

Conditions: Fed

Summary: the purpose of this study is to compare the rate and extent of absorption of dr. reddy's desloratadine 5 mg tablet to that of clarinex® 5 mg tablet in healthy subjects under fed conditions.

a randomized, single-dose, two-way crossover relative bioavailability study of desloratadine 5 mg tablet in fed normal,healthy subjects.

Eligibility criteria:
inclusion criteria: * is the individual a healthy, normal adult man and women who volunteers to participate? * is s/he within 18 and 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 weeks 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? a no answer to any of the above questions indicates that the individual is ineligible for enrollment exclusion criteria: does the individual have a history of 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 diseases 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-1, 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 used any tobacco products in the 3 months preceding drug administration? * has s/he received an investigational drug during the 30 day period preceding study initiation? a yes answer to any of the above questions indicates that the individual is ineligible for enrollment.