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

NCT01314352 | Completed Phase 1 DMC

• 1 other identifier: 50486
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Fed

Outcome Measures

Primary Outcomes (1)

• Bioavailability is based on Cmax and AUC parameters

  4 months

Study Arms (2)

Desloratadine Tablets, 5 mg

EXPERIMENTAL

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

Drug: Desloratadine

Clarinex

ACTIVE COMPARATOR

Clarinex® 5 mg Tablets of Schering-Plough

Drug: Desloratadine

Interventions

Desloratadine DRUG

Desloratadine Tablets, 5 mg

Also known as: Clarinex® 5 mg

Clarinex; Desloratadine Tablets, 5 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

SFBC, Ft. Myers, Inc.,

Fort Myers, Florida, 33901, United States

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antonio R. Pizarro, M.D.,

  SFBC Ft. Myers, Inc

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: December 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: March 1, 2006
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)