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CompletedNCT04534153Updated Nov 18, 2025

Excipient Effect on Drug Absorption in Humans

An Early Phase 1 interventional study of Fexofenadine Hydrochloride without sodium lauryl sulfate and Fexofenadine Hydrochloride with sodium lauryl sulfate in The Impact of Excipients on Drug Absorption, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by University of California, San Francisco · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 3 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • The Impact of Excipients on Drug Absorption
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugFexofenadine Hydrochloride without sodium lauryl sulfate

    without sodium lauryl sulfate

    Also known as: Allegra

  • DrugFexofenadine Hydrochloride with sodium lauryl sulfate

    with sodium lauryl sulfate

    Also known as: Allegra

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 0-48 hours

  2. Maximum Plasma Concentration (Cmax) of Fexofenadine

    To determine whether SLS decreases the fexofenadine Cmax between Fexofenadine + 3 mg SLS or Fexofenadine + 30 mg SLS and Fexofenadine only.

    Time frame: 0-48 hours

Secondary outcomes

  1. Sodium lauryl sulfate plasma concentration

    To determine plasma SLS concentration in order to understand the absorption of SLS in humans

    Time frame: 0-48 hours

  2. Fexofenadine stool amount

    To determine stool amount of fexofenadine and compare between the fexofenadine only arm to the 3 mg SLS and the 30 mg SLS arm.

    Time frame: 0-48 hours

  3. Sodium lauryl sulfate stool amount

    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.

    Time frame: 0-48 hours

07

Study locations

1 site
  • Ucsf Ctsi Crc
    San Francisco, California 94143, United States
08

References and documents

Study documents

  • Informed consent form · Jul 25, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Each participant's data will be de-identified before it is shared with others who meet specified access criteria.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04534153
Lead sponsor
University of California, San Francisco
Collaborators
Food and Drug Administration (FDA)
Responsible party
Sponsor
First posted
Sep 1, 2020
Start date
Jan 31, 2023
Primary completion
Jun 18, 2025
Completion
Aug 18, 2025
Last update
Nov 18, 2025

Study contacts

Katherine Yang, PharmD, MPH
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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