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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE HIVES

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505(b)(2) Clinical Trials for Fexofenadine Hydrochloride Hives

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01469234 A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712) Completed Bayer Phase 4 2011-10-01 The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.
New Dosage NCT02435563 Dose Adaptation to Offset the Interaction Between Ticagrelor and Ritonavir by Population-based PK Modeling Active, not recruiting University Hospital, Geneva Phase 2 2014-08-01 Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks. Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active metabolite. Because of the remarkable progress in HIV therapies the number of older age patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is contraindicated in these patients because of the expected interaction and bleeding risk. A lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of ritonavir has been already demonstrated. Therefore, administration of a lower dose of ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as administered alone using a physiologically-based pharmacokinetic (PBPK) model. As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will be created based on available in vitro and in vivo parameters in healthy volunteers. An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the volunteers and obtained pharmacokinetic data will be fitted into the model for optimization. Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize the magnitude of this interaction will be calculated. This new dose will be co-administered with ritonavir in the same volunteers during the second session of the clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both sessions of the clinical trial using two specific platelet function tests: the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as probe substrates. The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to broaden the application field of ticagrelor, especially in HIV patients. Since PK models are often created after clinical observations, the prospective aspect of this study is of particular value as the model will be first created and then applied to an unknown clinical scenario.
OTC NCT03425097 Fexofenadine Use in Gastroesophageal Reflux Disease Recruiting Stanford University Phase 2 2018-02-07 The investigators wish to study the effectiveness of Fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fexofenadine Hydrochloride Hives

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00029692 Effects of Ginseng and Ginkgo on Drug Disposition in Man Completed National Center for Complementary and Integrative Health (NCCIH) Phase 2 2002-03-01 This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes that process drugs, and 3) enzymes that may help prevent cancer.
NCT00044811 Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma Completed Sanofi Phase 3 2002-03-01 The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
NCT00044824 Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma Completed Sanofi Phase 3 2002-02-01 The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
NCT00045955 Long-Term Safety Performance of Fexofenadine in Asthma Completed Sanofi Phase 3 2002-02-01 The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fexofenadine Hydrochloride Hives

Condition Name

Condition Name for Fexofenadine Hydrochloride Hives
Intervention Trials
Healthy 15
Seasonal Allergic Rhinitis 8
Allergic Rhinitis 6
Rhinitis, Allergic, Seasonal 3
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Condition MeSH

Condition MeSH for Fexofenadine Hydrochloride Hives
Intervention Trials
Rhinitis, Allergic 24
Rhinitis 24
Rhinitis, Allergic, Seasonal 14
Pruritus 3
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Clinical Trial Locations for Fexofenadine Hydrochloride Hives

Trials by Country

Trials by Country for Fexofenadine Hydrochloride Hives
Location Trials
United States 41
Switzerland 6
Canada 5
France 4
Korea, Republic of 3
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Trials by US State

Trials by US State for Fexofenadine Hydrochloride Hives
Location Trials
New Jersey 10
Texas 3
Maryland 2
Kansas 2
North Dakota 2
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Clinical Trial Progress for Fexofenadine Hydrochloride Hives

Clinical Trial Phase

Clinical Trial Phase for Fexofenadine Hydrochloride Hives
Clinical Trial Phase Trials
Phase 4 26
Phase 3 7
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Fexofenadine Hydrochloride Hives
Clinical Trial Phase Trials
Completed 49
Recruiting 6
Active, not recruiting 3
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Clinical Trial Sponsors for Fexofenadine Hydrochloride Hives

Sponsor Name

Sponsor Name for Fexofenadine Hydrochloride Hives
Sponsor Trials
Sanofi 15
Merck Sharp & Dohme Corp. 5
Dr. Reddy's Laboratories Limited 5
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Sponsor Type

Sponsor Type for Fexofenadine Hydrochloride Hives
Sponsor Trials
Industry 45
Other 20
NIH 4
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