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

NCT ID: NCT01506791

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-04-30

Brief Summary

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

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Desloratadine and pseudoephedrine ER tablets 5/240 mg

Desloratadine and pseudoephedrine ER tablets 5/240 mg of Dr. Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Desloratadine and pseudoephedrine

Intervention Type: DRUG

Desloratadine and pseudoephedrine 5/240 mg

Clarinex D 24-hour

Clarinex D-24 of Schering Corporation Inc USA

Group Type: ACTIVE_COMPARATOR

Desloratadine and pseudoephedrine

Intervention Type: DRUG

Desloratadine and pseudoephedrine 5/240 mg

Interventions

Desloratadine and pseudoephedrine

Desloratadine and pseudoephedrine 5/240 mg

Intervention Type: DRUG

Other Intervention Names

Clarinex D-24

Eligibility Criteria

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?

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio R Pizarro, MD

Role: PRINCIPAL_INVESTIGATOR

SFBC Anapharm

Locations

SFBC Ft Myers Inc

Broadway, Florida, United States

Countries

United States

Other Identifiers

50631

Identifier Type: -

Identifier Source: org_study_id