Fexofenadine Hydrochloride with sodium lauryl sulfate for The Impact of Excipients on Drug Absorption

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ucsf Ctsi Crc, San Francisco, CAThe Impact of Excipients on Drug AbsorptionFexofenadine Hydrochloride with sodium lauryl sulfate - Drug
Eligibility
18 - 64
All Sexes
What conditions do you have?
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Study Summary

This trial will compare how well drugs are absorbed when taken with different amounts of sodium lauryl sulfate.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 0-48 hours

0-48 hours
Area under the plasma concentration versus time curve (AUC) of Fexofenadine
Fexofenadine stool amount
Maximum Plasma Concentration (Cmax) of Fexofenadine
Sodium lauryl sulfate plasma concentration
Sodium lauryl sulfate stool amount

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Fexofenadine without SLS
1 of 3
Fexofenadine and 3 mg SLS
1 of 3
Fexofenadine and 30 mg SLS
1 of 3

Experimental Treatment

12 Total Participants · 3 Treatment Groups

Primary Treatment: Fexofenadine Hydrochloride with sodium lauryl sulfate · No Placebo Group · Phase < 1

Fexofenadine without SLS
Drug
Experimental Group · 1 Intervention: Fexofenadine Hydrochloride without sodium lauryl sulfate · Intervention Types: Drug
Fexofenadine and 3 mg SLS
Drug
Experimental Group · 1 Intervention: Fexofenadine Hydrochloride with sodium lauryl sulfate · Intervention Types: Drug
Fexofenadine and 30 mg SLS
Drug
Experimental Group · 1 Intervention: Fexofenadine Hydrochloride with sodium lauryl sulfate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0-48 hours

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,312 Previous Clinical Trials
11,758,314 Total Patients Enrolled
Food and Drug Administration (FDA)FED
154 Previous Clinical Trials
953,829 Total Patients Enrolled
Kathleen M Giacomini, Ph.D.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
20 Total Patients Enrolled
Deanna Kroetz, Ph.D.Principal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18 - 64 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People of all ethnicities and races who are in good health can participate.
You are willing to avoid drinking fruit juices and taking supplements containing grapefruit extract, hesperidin, or naringin for the entire study period.

Frequently Asked Questions

Is this study only available to people under the age of 40?

"According to the screening process for this study, patients must be between 18-64 years old." - Anonymous Online Contributor

Unverified Answer

What is Fexofenadine Hydrochloride with sodium lauryl sulfate generally used to treat?

"Fexofenadine Hydrochloride with sodium lauryl sulfate can be used to relieve symptoms for individuals suffering from allergic rhinitis (disorder), chronic idiopathic urticaria, and seasonal allergic rhinitis." - Anonymous Online Contributor

Unverified Answer

Are there any other recorded instances of Fexofenadine Hydrochloride being used in conjunction with sodium lauryl sulfate?

"There are currently 5 ongoing clinical trials investigating the efficacy of Fexofenadine Hydrochloride with sodium lauryl sulfate. Of these 5 trials, 2 have progressed to Phase 3. Most of the research is being conducted in Salt Lake City, but Fexofenadine Hydrochloride with sodium lauryl sulfate trials are also taking place at 20 other locations." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial have any prerequisites for participants?

"This clinical trial is looking for 12 participants with the impact of excipients on drug absorption aged 18 and 64. Most notable, candidates must meet the following criteria: Subjects who are willing to avoid ingestion of fruit juices and citrus bioflavonoids, such as grapefruit extract, hesperidin supplement and naringin supplement, for a period extending from one week prior to the initiation of the study until its completion., Healthy volunteers of all ethnic groups and races., Male and females between the ages of 18-64 years old, inclusive." - Anonymous Online Contributor

Unverified Answer

What is the size of the test group for this experiment?

"This research is not presently looking for patients to enroll. The trial was originally advertised on October 1st, 2020 and the most recent update was on September 7th, 2020. If you are interested in other studies, there are 1 trials concerning excipient's impact on drug absorption and 5 trials for Fexofenadine Hydrochloride with sodium lauryl sulfate that are actively recruiting participants." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.