Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions

Dr.Reddy's Laboratories

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Desloratadine and pseudoephedrine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01506791

50631

Details and patient eligibility

About

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

Full description

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation, U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg extended-release tablet under fed conditions. The treatment phases were separated by a washout period of 14 days. 44 subjects were dosed and were enrolled in the study; 43 of these enrolled subjects completed the study.

Enrollment

44 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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?

Exclusion criteria

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