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

NCT01506791 | Completed Phase 1

• 1 other identifier: 50631
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioequivalence; Desloratadine and pseudoephedrine; crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve(AUC)

  Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose

Study Arms (2)

Desloratadine and pseudoephedrine ER tablets 5/240 mg

EXPERIMENTAL

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

Drug: Desloratadine and pseudoephedrine

Clarinex D 24-hour

ACTIVE COMPARATOR

Clarinex D-24 of Schering Corporation Inc USA

Drug: Desloratadine and pseudoephedrine

Interventions

Desloratadine and pseudoephedrine DRUG

Desloratadine and pseudoephedrine 5/240 mg

Also known as: Clarinex D-24

Clarinex D 24-hour; Desloratadine and pseudoephedrine ER tablets 5/240 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 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?

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

SFBC Ft Myers Inc

Broadway, Florida, 33901, United States

Location

MeSH Terms

Interventions

desloratadine; Pseudoephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Antonio R Pizarro, MD

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: January 10, 2012
• Study Start: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: January 10, 2012

Record last verified: 2006-06

Locations

US (1)