Fed
Conditions
Brief 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.
Detailed description
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in fed Normal,Healthy subjects.
Interventions
DRUGDesloratadine
Desloratadine Tablets, 5 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability is based on Cmax and AUC parameters | 4 months |
Countries
United States
Outcome results
None listed