Clinical trial NCT01314352: Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed Conditions
Official title: A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Healthy Subjects Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fed
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bioavailability is based on Cmax and AUC parameters
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Myers
country: United States
facility: SFBC, Ft. Myers, Inc.,
state: Florida
Study officials:
affiliation: SFBC Ft. Myers, Inc
name: Antonio R. Pizarro, M.D.,
role: PRINCIPAL_INVESTIGATOR
References: