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

NCT ID: NCT01314352

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2006-03-31

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.

Detailed Description

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

Conditions

Fed

Study Design

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

Study Groups

Desloratadine Tablets, 5 mg

Desloratadine Tablets, 5 mg of Dr. Reddy's Laboratories

Group Type: EXPERIMENTAL

Desloratadine

Intervention Type: DRUG

Desloratadine Tablets, 5 mg

Clarinex

Clarinex® 5 mg Tablets of Schering-Plough

Group Type: ACTIVE_COMPARATOR

Desloratadine

Intervention Type: DRUG

Desloratadine Tablets, 5 mg

Interventions

Desloratadine

Desloratadine Tablets, 5 mg

Intervention Type: DRUG

Other Intervention Names

Clarinex® 5 mg

Eligibility Criteria

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.

• 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

Dr. Reddy's Laboratories Limited

Principal Investigators

Antonio R. Pizarro, M.D.,

Role: PRINCIPAL_INVESTIGATOR

SFBC Ft. Myers, Inc

Locations

SFBC, Ft. Myers, Inc.,

Fort Myers, Florida, United States

Countries

United States

Other Identifiers

50486

Identifier Type: -

Identifier Source: org_study_id