Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition

Completed · Phase 1

Conditions studied: Healthy

In brief

This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.

Key facts

Study ID

NCT01506037

Run by

Dr. Reddy's Laboratories Limited

People needed

36

Starts

2006-01-01

Expected to finish

2006-02-01

Last updated by the study team

2012-01-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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?

You may not qualify if…

• Does the individual have a history or allergy or hypersensitivity to desloratadine, 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?

Where it is running

• SFBC Ft Myers Inc — Broadway, Florida, United States

Full record on ClinicalTrials.gov

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