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| Sponsor: | 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: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00636870 History of Changes |
| Other Study ID Numbers: | M016455_4124 |
| Study First Received: | March 10, 2008 |
| Last Updated: | January 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Fexofenadine Terfenadine Desloratadine Anti-Allergic Agents Therapeutic Uses |
Pharmacologic Actions Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cholinergic Antagonists Cholinergic Agents |