Fasting Clinical Trial
Official title:
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Healthy Subjects 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.
Status | Completed |
Enrollment | 28 |
Est. completion date | February 2006 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | SFBC, Ft. Myers, Inc., | Ft. Myers | Florida |
Lead Sponsor | Collaborator |
---|---|
Dr. Reddy's Laboratories Limited |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioavailability is based on Cmax and AUC parameters | 3 months | No |
Status | Clinical Trial | Phase | |
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