DeepMed Research

Fexofenadine

Generic Name: Fexofenadine

Brand Names: Allegra, Allegra-D, Mucinex Non-drowsy Allergy, Wal-fex, Telfast

Drug Type: Small Molecule

Chemical Formula: C_₃₂H_₃₉NO_₄

CAS Number: 83799-24-0

Unique Ingredient Identifier: E6582LOH6V

Background: Fexofenadine is an over-the-counter second-generation antihistamine used in the treatment of various allergic symptoms. It is selective for the H receptor, carries little-to-no activity at off-targets, and does not cross the blood-brain barrier - this is in contrast to previous first-generation antihistamines, such as diphenhydramine, which readily bind to off-targets that contribute to side effects such as sedation. Fexofenadine is the major active metabolite of terfenadine and is administered as a racemic mixture in which both enantiomers display approximately equivalent antihistamine activity.

Indication: In the United States, fexofenadine is indicated for the symptomatic treatment of allergic rhinitis in patients ≥2 years old and chronic idiopathic urticaria in patients ≥6 months old. In Canada, fexofenadine carries the same indications but is approved only for patients ≥12 years old. Fexofenadine is also available in combination with pseudoephedrine for the symptomatic treatment of season allergic rhinitis in patients ≥12 years old.

Associated Conditions: Allergic Rhinitis (AR), Chronic Idiopathic Urticaria, Seasonal Allergic Rhinitis

Associated Therapies: Antihistamine

Clinical Trials

Evaluation of Efficacy of Dellegra in Exposure Unit

Phase 4

Completed

Conditions: Rhinitis Allergic

Interventions: Drug: Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg

First Posted Date: 2014-06-26

Last Posted Date: 2015-12-18

Lead Sponsor: Sanofi

Target Recruit Count: 24

Registration Number: NCT02175485

Locations: 🇯🇵
Investigational Site Number 392-001, Shinjuku-ku, Japan

Relative Bioavailability of Dabigatran Etexilate Capsules With and Without Quinidine Sulfate Tablets and to Measure the Effect of Quinidine on the Absorption of Fexofenadine in Healthy Male and Female Volunteers

Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate capsules
Drug: Fexofenadine tablets
Drug: Quinidine sulfate tablets

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 42

Registration Number: NCT02171546

An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects

Phase 1

Completed

Conditions: Drug Interactions

Interventions: Drug: Fexofenadine
Drug: Telotristat etiprate

First Posted Date: 2014-06-06

Last Posted Date: 2014-09-08

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 24

Registration Number: NCT02157558

Locations: 🇺🇸
Lexicon Investigational Site, Dallas, Texas, United States

Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: CYP cocktail
Drug: Fexofenadine 30mg
Dietary Supplement: Red ginseng
Dietary Supplement: Fermented-red ginseng

First Posted Date: 2014-02-06

Last Posted Date: 2014-02-06

Lead Sponsor: Chonbuk National University Hospital

Target Recruit Count: 30

Registration Number: NCT02056743

Locations: 🇰🇷
Clinical Trial Center of Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of

Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria

Phase 4

Completed

Conditions: Urticaria

Interventions: Drug: Ebastine
Drug: Cetirizine
Drug: Desloratadine
Drug: Fexofenadine
Drug: Bilastine

First Posted Date: 2013-09-12

Last Posted Date: 2014-02-19

Lead Sponsor: Grupo de Alergología Clínica y Experimental

Target Recruit Count: 150

Registration Number: NCT01940393

Locations: 🇨🇴
Medellin, Medellin, Antioquia, Colombia

Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Fexofenadine Hydrochloride

First Posted Date: 2013-06-28

Last Posted Date: 2013-06-28

Lead Sponsor: Dr. Reddy's Laboratories Limited

Target Recruit Count: 80

Registration Number: NCT01888718

Locations: 🇮🇳
Bioserve Clinical Research Private Limited, Balanagar, Hyderabad, Andhra Pradesh, India

Pregabalin for the Treatment of Uremic Pruritus

Phase 4

Conditions: Uremic Pruritus

Interventions: Drug: pregabalin 75mg daily for 12 weeks
Drug: fexofenadine 60 mg daily for 12 weeks
Drug: placebo

First Posted Date: 2013-05-13

Last Posted Date: 2014-04-15

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 210

Registration Number: NCT01852318

Locations: 🇨🇳
National Taiwan University (NTUH); NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch; Cathay General hospital, Taipei, Taiwan

Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: fexofenadine

First Posted Date: 2013-01-14

Last Posted Date: 2013-01-14

Lead Sponsor: Damanhour University

Target Recruit Count: 25

Registration Number: NCT01767272

Aprepitant in the Management of Biological Therapies-related Severe Pruritus

Phase 2

Completed

Conditions: ITCH

Interventions: Drug: Aprepitant
Drug: Prednisone
Drug: Fexofenadine

First Posted Date: 2012-09-12

Last Posted Date: 2012-09-12

Lead Sponsor: Campus Bio-Medico University

Target Recruit Count: 45

Registration Number: NCT01683552

Locations: 🇮🇹
Campus Bio-Medico of Rome University, Roma, Italy

Safety Study of Levocetirizine and Fexofenadine

Phase 4

Completed

Conditions: Pruritus
Chronic Urticaria
Allergic Rhinitis

Interventions: Drug: Placebo Oral Tablet
Drug: Levocetirizine Oral Tablet
Drug: Fexofenadine 60 Mg Oral Tablet

First Posted Date: 2012-04-26

Last Posted Date: 2019-10-04

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 18

Registration Number: NCT01586091

Locations: 🇩🇪
University of Berlin Charité, Department of Dermatology and Allergy, Berlin, Germany

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