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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01506791
First received: September 27, 2011
Last updated: January 5, 2012
Last verified: June 2006

September 27, 2011
January 5, 2012
April 2006
Not Provided
Area under curve(AUC) [ Time Frame: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01506791 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fed Conditions

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

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-D® 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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Desloratadine and pseudoephedrine
Desloratadine and pseudoephedrine 5/240 mg
Other Name: Clarinex D-24
  • Experimental: Desloratadine and pseudoephedrine ER tablets 5/240 mg
    Desloratadine and pseudoephedrine ER tablets 5/240 mg of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Desloratadine and pseudoephedrine
  • Active Comparator: Clarinex D 24-hour
    Clarinex D-24 of Schering Corporation Inc USA
    Intervention: Drug: Desloratadine and pseudoephedrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2006
Not Provided

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?
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01506791
50631
No
Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Antonio R Pizarro, MD SFBC Anapharm
Dr. Reddy's Laboratories Limited
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP