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

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314339
• Other study ID #: 50485
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2011
• Last updated: February 17, 2012
• Start date: December 2005
• Est. completion date: February 2006

Study information

• Verified date: September 2005
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 fasting conditions.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasting

Intervention

Drug:
• Desloratadine
Desloratadine Tablets, 5 mg

Locations

Country	Name	City	State
United States	SFBC, Ft. Myers, Inc.,	Ft. Myers	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability is based on Cmax and AUC parameters		3 months	No