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Excipient Impact on Drug Absorption

Q: 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.

Q: 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.

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/all">all</a> ethnic groups and races., Male and females between the ages of 18-64 years old, inclusive.

Q: 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.

Phase < 1

Recruiting

Led By Kathleen M Giacomini, Ph.D.

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and females between the ages of 18-64 years old, inclusive

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-48 hours

Awards & highlights

Study Summary

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

Who is the study for?

Healthy adults aged 18-64, willing to avoid certain fruit juices and supplements, can join this trial. They must not be extremely obese, allergic to the drug or its components, have low hemoglobin levels, be pregnant/breastfeeding without birth control use, or have liver/kidney/heart diseases.Check my eligibility

What is being tested?

The study is testing how a common non-drug ingredient called sodium lauryl sulfate (SLS) affects the absorption of Fexofenadine Hydrochloride. Participants will take the drug with varying amounts of SLS to see if there's any difference in how well their body absorbs it.See study design

What are the potential side effects?

While specific side effects are not listed for this trial scenario since it involves healthy volunteers and a commonly used medication component (SLS), typical reactions might include digestive discomfort or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration versus time curve (AUC) of Fexofenadine

Maximum Plasma Concentration (Cmax) of Fexofenadine

Secondary outcome measures

Fexofenadine stool amount

Sodium lauryl sulfate plasma concentration

Sodium lauryl sulfate stool amount

Trial Design

3Treatment groups

Experimental Treatment

Group I: Fexofenadine without SLSExperimental Treatment1 Intervention

Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride and 101 mg microcrystalline cellulose

Group II: Fexofenadine and 30 mg SLSExperimental Treatment1 Intervention

Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 30 mg SLS and 101 mg microcrystalline cellulose

Group III: Fexofenadine and 3 mg SLSExperimental Treatment1 Intervention

Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 3 mg SLS and 101 mg microcrystalline cellulose

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,543 Total Patients Enrolled

Food and Drug Administration (FDA)FED

171 Previous Clinical Trials

1,331,594 Total Patients Enrolled

Kathleen M Giacomini, Ph.D.Principal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Excipient Effect on Drug Absorption in Humans

2023. "Excipient Effect on Drug Absorption in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04534153.