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Does this everyday ingredient mess with your meds?

NCT ID NCT04534153

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether sodium lauryl sulfate (SLS), a common ingredient in many drug products, changes how the allergy drug fexofenadine (Allegra) is absorbed in the body. Twelve healthy adults took fexofenadine alone or with low or high amounts of SLS. Researchers measured drug levels in the blood and stool to see if SLS affects absorption.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium lauryl sulfate (SLS) added to fexofenadine (Allegra)
What this could lead to
If it works, this could help design better drug formulations that avoid unintended changes in drug absorption.
What could go wrong
This is a very small, early-phase study in 12 healthy people, so results may not apply to other drugs or populations. It only looks at absorption, not safety or effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

12 people

The number who actually took part.

Started

Jan 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ucsf Ctsi Crc

    San Francisco, California, 94143, United States