Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Desloratadine

• Registration Number: NCT01506037
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

This is an open label, randomised, single dose, 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 ODT 5 mg and Schering Corporation, U.S.A.(Clarinex® 5 mg), desloratadine ODT 5 mg under fed conditions. The treatment phases were separated by a washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 36 of these enrolled subjects completed the study.

Study Timeline

• Study Start: 2006-01
• Study Completion: 2006-02
• Status Verified: 2006-05
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-09
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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?

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Exclusion Criteria

• 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?

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clarinex	Desloratadine	Clarinex 5 mg of Schering Corporation Inc USA
Desloratadine OD tablets 5 mg	Desloratadine	Desloratadine OD tablets 5 mg of Dr. Reddy's Laboratories Limited

Primary Outcome Measures

Name	Time	Method
Area under curve(AUC)	Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120 and 144 hours post-dose

Trial Locations

Locations (1)

SFBC Ft Myers Inc; 🇺🇸 Broadway, Florida, United States