Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed Conditions

• Sponsor: Dr. Reddy's Laboratories Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01314352
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

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 fed conditions.

Condition or Disease	Intervention/Treatment	Phase
Fed	Drug: Desloratadine	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Desloratadine 5 mg Tablet in Healthy Subjects Under Fed Conditions
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bioavailability is based on Cmax and AUC parameters [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SFBC, Ft. Myers, Inc.,	Ft. Myers	Florida	United States	33901

Sponsors and Collaborators

• Dr. Reddy's Laboratories Limited

Investigators

• Principal Investigator: Antonio R. Pizarro, M.D.,, SFBC Ft. Myers, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01314352
• Other Study ID Numbers: 50486
• First Posted: Mar 14, 2011
• Last Update Posted: Jun 8, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Malnutrition; Desloratadine

Study Results

No Results Posted as of Jun 8, 2011