Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Fexofenadine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Phyllis Diener, Study Director, Affiliation: Sanofi-Aventis
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Crossover Assignment
Primary outcome: Endpoints will be the AUC and Cmax for desloratadine, 3-OH desloratadine, and fexofenadine.
Secondary outcome: Endpoints will include Tmax, elimination half-life (t1/2), and accumulation index, as the data permit.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Additional Information
clinicalstudyresults.org
Starting date: February 2003
Ending date: January 2004
Last updated: April 1, 2008
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