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

Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636870
• Other study ID #: M016455_4124
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2008
• Last updated: January 10, 2011
• Start date: February 2003
• Est. completion date: January 2004

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• Fexofenadine

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endpoints will be the AUC and Cmax for desloratadine, 3-OH desloratadine, and fexofenadine.		Serial, Trough, and Terminal blood samples over 8 days.	No
Secondary	Endpoints will include Tmax, elimination half-life (t1/2), and accumulation index, as the data permit.		Serial, Trough, and Terminal blood samples over 8 days.	No