Healthy
Conditions
Keywords
Bioequivalence, Desloratadine and pseudoephedrine, crossover
Brief summary
This is an open label, randomised, 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-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.
Interventions
Desloratadine and pseudoephedrine 5/240 mg
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under curve(AUC) | Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose |
Countries
United States
Outcome results
None listed