Back to resultsFexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fexofenadine
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Endpoints will be the AUC and Cmax for desloratadine, 3-OH desloratadine, and fexofenadine.
Secondary Outcome Measures
Endpoints will include Tmax, elimination half-life (t1/2), and accumulation index, as the data permit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00636870
Brief Title
Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fexofenadine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phyllis Diener
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine
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