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Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636870
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : January 11, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Fexofenadine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : February 2003
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00636870

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
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Study Director: Phyllis Diener Sanofi
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Responsible Party: Study Director, sanofi-aventis Identifier: NCT00636870    
Other Study ID Numbers: M016455_4124
First Posted: March 17, 2008    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs