bioequivalence study of desloratadine and pseudoephedrine extended-release tablets under fed conditions

Conditions: Healthy

Summary: 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.

Eligibility criteria:
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?

Keywords: bioequivalence desloratadine and pseudoephedrine crossover