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Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Desloratadine and pseudoephedrine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Antonio R Pizarro, MD, Principal Investigator, Affiliation: SFBC Anapharm

Summary

This is an open label, randomised, 2-way crossover, comparative bioequivalence study.

Clinical Details

Official title: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-DŽ 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fed Conditions

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

Primary outcome: Area under curve(AUC)

Detailed description: The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation, U. S.A.(Clarinex-DŽ 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg extended-release tablet under fed conditions. The treatment phases were separated by a washout period of 14 days. 44 subjects were dosed and were enrolled in the study; 43 of these enrolled subjects completed the study.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Is the individual a healthy, normal adult man or woman who volunteers to participate?

- Is s/he within 18 to 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 week 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?

Exclusion Criteria:

- Does the individual have a history or allergy or hypersensitivity to desloratadine or

pseudoephedrine, milk or eggs?

- 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 disease 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-I, 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 received an investigational drug during the 30 day period preceding study

initiated?

- Has s/he used any tobacco products in the 3 months preceding drug administration?

Locations and Contacts

SFBC Ft Myers Inc, Broadway, Florida 33901, United States
Additional Information

Starting date: April 2006
Last updated: January 5, 2012

Page last updated: August 23, 2015

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