Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions.

A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Healthy Subjects Under Fasting Conditions

The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fasting conditions.

Study Overview

• Status: Completed
• Conditions: Fasting
• Intervention / Treatment: Drug: Desloratadine

Detailed Description

A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Fasted Normal,Healthy subjects.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ft. Myers, Florida, United States, 33901
      • SFBC, Ft. Myers, Inc.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Is the individual a healthy, normal adult man and women who volunteers to participate?
• Is s/he within 18 and 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 weeks 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?

A no answer to any of the above questions indicates that the individual is ineligible for enrollment

Exclusion Criteria:

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

• 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 diseases 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-1, 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 used any tobacco products in the 3 months preceding drug administration?
• Has s/he received an investigational drug during the 30 day period preceding study initiation? A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desloratadine Tablets, 5 mg; Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories	Drug: Desloratadine; Desloratadine Tablets, 5 mg; Other Names: Clarinex® 5 mg
Active Comparator: Clarinex; Clarinex® 5 mg Tablets of Schering-Plough	Drug: Desloratadine; Desloratadine Tablets, 5 mg; Other Names: Clarinex® 5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioavailability is based on Cmax and AUC parameters	3 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Antonio R. Pizarro, M.D.,, SFBC Ft. Myers, Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Desloratadine
• Other Study ID Numbers: 50485

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No