Full Text View
Tabular View
No Study Results Posted
Related Studies
Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine
This study has been completed.
First Received: March 10, 2008   Last Updated: April 1, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00636870
  Purpose

To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.


Condition Intervention Phase
Allergic Rhinitis
Drug: Fexofenadine
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Crossover Assignment
Official Title: A Randomized, Double-Blind, Repeat-Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Desloratadine (Clarinex®) Compared to Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine.

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Endpoints will be the AUC and Cmax for desloratadine, 3-OH desloratadine, and fexofenadine. [ Time Frame: Serial, Trough, and Terminal blood samples over 8 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endpoints will include Tmax, elimination half-life (t1/2), and accumulation index, as the data permit. [ Time Frame: Serial, Trough, and Terminal blood samples over 8 days. ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: February 2003
Study Completion Date: January 2004
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy, adult, non-smoking males and females between 18 and 55 years of age, inclusive; Whites of European or North American heritage and Blacks of African or Caribbean heritage.

Exclusion Criteria:

  • Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study.
  • Historical, clinical, or laboratory evidence of liver disease including but not limited to transaminase activity concentrations >2.5 times the upper limit of the reference range.
  • Active peptic ulcer disease or a history of gastrointestinal surgery within the last 6 months.
  • History of cholecystectomy.
  • History of malignancy within the last 5 years (except basal cell carcinoma, which must be in remission for at least 6 months prior to the study.
  • Pregnant or lactating females or females of childbearing potential who are unwilling to use reliable, medically accepted methods of contraception.

If subjects who are not sexually active with members of the opposite sex become so during the study, these subjects must agree to use a medically accepted method of contraception.

  • History of hypersensitivity or intolerability to either desloratadine or fexofenadine or other antihistamines.
  • Treatment with other antihistamines in the last month before study entry.
  • Use of any prescription or over-the-counter medications or dietary/herbal supplements (with the exception of oral or implanted contraceptives) within 1 week or 5 half-lives, whichever is longer, of the study.
  • History of alcoholism or drug abuse within 12 months of the study.
  • Ingestion of alcohol within 1 week of the first dose of study medication.
  • Ingestion of grapefruit or grapefruit juice within 1 week of the study and a willingness to abstain from the consumption of grapefruit or grapefruit juice for the duration of the study.
  • Participation in any other clinical trial or use of an investigational product within 30 days of entry into the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636870

Locations
United States, New Jersey
Sanofi-aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Phyllis Diener Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Responsible Party: sanofi-aventis ( Study Director )
Study ID Numbers: M016455/4124
Study First Received: March 10, 2008
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00636870     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Cholinergic Antagonists
Rhinitis
Healthy
Anti-Allergic Agents
Cholinergic Agents
Desloratadine
Histamine
Respiratory Tract Diseases
Respiratory Tract Infections
Histamine Antagonists
Fexofenadine
Histamine H1 Antagonists
Histamine phosphate

Additional relevant MeSH terms:
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agents
Rhinitis
Anti-Allergic Agents
Cholinergic Agents
Desloratadine
Nose Diseases
Pharmacologic Actions
Respiratory Tract Diseases
Respiratory Tract Infections
Histamine Antagonists
Therapeutic Uses
Fexofenadine
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on July 02, 2009