Excipient Effect on Drug Absorption in Humans

November 14, 2025 updated by: University of California, San Francisco

The Effect of Sodium Lauryl Sulfate on the Oral Absorption of Fexofenadine in Humans

The purpose of this study is to determine if sodium lauryl sulfate (SLS), a non-drug ingredient commonly added in drug products, affect absorption of drugs that are given together with the ingredient. Investigators want to find out if drug absorption is different in people taking the drug alone compared to people taking the drug with low and high amounts of sodium lauryl sulfate at the same time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-center, randomized, double-blind, 3-period crossover trial. Participants will be randomized to receive a Control capsule (fexofenadine single agent) under Treatment Arm 1 or a Test 1 capsule (fexofenadine and 3 mg SLS) under Treatment Arm 2 or Test 2 capsule (fexofenadine and 30 mg SLS) under Treatment Arm 3. Investigators will assess the effect of SLS on the absorption of fexofenadine by measuring SLS and fexofenadine concentrations in plasma and stool samples and determine the change in AUC (area under the curve), Cmax and other pharmacokinetic parameters, between Treatment Arms 2 or 3 and Treatment Arm 1.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Ucsf Ctsi Crc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy volunteers of all ethnic groups and races.
  2. Male and females between the ages of 18-64 years old, inclusive.
  3. 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.
  4. Written informed consent obtained from the subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  1. Subjects with extreme obesity (BMI > 35).
  2. Subjects who are allergic to fexofenadine or SLS.
  3. Subjects who have hemoglobin level lower than 12 g/dL.
  4. Subjects who are pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  5. Subjects with chronic constipation.
  6. Subjects consuming types of food and supplements with the potential to interfere with the study objectives as judged by the Investigator.
  7. Subjects taking any drugs, especially known OATP2B1 substrates (aliskiren, atenolol, celiprolol, fexofenadine, rosuvastatin and ticlopidine, etc.) except birth control hormonal medications.
  8. Subjects with a condition, disease, or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
  9. Subjects with any disease affecting or impairing the function of the liver, kidney, or heart.
  10. Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery.
  11. Subjects with known infection with HIV, Hepatitis B or Hepatitis C (as determined by questionnaire, no laboratory diagnostics concerning these diseases will be performed within the present study). Volunteers who are cured of past Hepatitis C infection are eligible to participate with a doctor's approval letter.
  12. Subjects who are smokers or have smoked in the past year and/or have smoked or ingested THC/marijuana in the past week, or who are unwilling to comply throughout the study period.
  13. Alcohol use on average > 2 servings/day or > 14 servings/wk (Serving size: 12oz beer/4oz wine/2oz hard liquor) in the past week or self-reported binge drinking.
  14. Subjects who are currently receiving any investigational agent or who have received any investigational agents within a period of 5 half-lives of the agent prior to the initiation of the current study.
  15. Subjects who have donated whole blood within 8 weeks prior to study initiation or plan to donate blood during the study period.
  16. Non-English speaking.
  17. Subjects with abnormal laboratory results at Screening Visit as judged by the Investigator or study physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fexofenadine without SLS
Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride and 101 mg microcrystalline cellulose
Drug: Fexofenadine Hydrochloride without sodium lauryl sulfate
without sodium lauryl sulfate
Other Names:
  • Allegra
Experimental: Fexofenadine and 3 mg SLS
Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 3 mg SLS and 101 mg microcrystalline cellulose
Drug: Fexofenadine Hydrochloride with sodium lauryl sulfate
with sodium lauryl sulfate
Other Names:
  • Allegra
Experimental: Fexofenadine and 30 mg SLS
Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 30 mg SLS and 101 mg microcrystalline cellulose
Drug: Fexofenadine Hydrochloride with sodium lauryl sulfate
with sodium lauryl sulfate
Other Names:
  • Allegra

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC) of Fexofenadine
Time Frame: 0-48 hours
To determine whether SLS decreases the fexofenadine area under the curve (AUC) between Fexofenadine + 3 mg SLS or Fexofenadine + 30 mg SLS and Fexofenadine only.
0-48 hours
Maximum Plasma Concentration (Cmax) of Fexofenadine
Time Frame: 0-48 hours
To determine whether SLS decreases the fexofenadine Cmax between Fexofenadine + 3 mg SLS or Fexofenadine + 30 mg SLS and Fexofenadine only.
0-48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sodium lauryl sulfate plasma concentration
Time Frame: 0-48 hours
To determine plasma SLS concentration in order to understand the absorption of SLS in humans
0-48 hours
Fexofenadine stool amount
Time Frame: 0-48 hours
To determine stool amount of fexofenadine and compare between the fexofenadine only arm to the 3 mg SLS and the 30 mg SLS arm.
0-48 hours
Sodium lauryl sulfate stool amount
Time Frame: 0-48 hours
To determine stool amount of sodium lauryl sulfate and compare between the fexofenadine only arm to the 3 mg SLS and the 30 mg SLS arm.
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Food and Drug Administration (FDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Yang, PharmD, MPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-31871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Each participant's data will be de-identified before it is shared with others who meet specified access criteria.

IPD Sharing Time Frame

Once after publication

IPD Sharing Access Criteria

De-identified specimens may be shared with other researchers so they can use them for, but not limited to, genomic, epigenetic, metabolomic, proteomic and transcriptomic follow-up studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Dietary Supplements

Sponsor/Collaborators

Locations

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