Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions.
Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions.
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 fasting
 conditions.
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine
 5 mg Tablet in Fasted Normal,Healthy subjects.
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.