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| Sponsored by: |
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: | Treatment, Randomized, Double-Blind, Crossover Assignment |
| 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:
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.
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Study Director ) |
| Study ID Numbers: | M016455/4124 |
| Study First Received: | March 10, 2008 |
| Last Updated: | April 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00636870 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Otorhinolaryngologic Diseases Cholinergic Antagonists Rhinitis Healthy Anti-Allergic Agents Cholinergic Agents Desloratadine |
Histamine Respiratory Tract Diseases Respiratory Tract Infections Histamine Antagonists Fexofenadine Histamine H1 Antagonists Histamine phosphate |
|
Neurotransmitter Agents Otorhinolaryngologic Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Rhinitis Anti-Allergic Agents Cholinergic Agents Desloratadine |
Nose Diseases Pharmacologic Actions Respiratory Tract Diseases Respiratory Tract Infections Histamine Antagonists Therapeutic Uses Fexofenadine Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |