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
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.
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.
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.
Exclusion Criteria:
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
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
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
without sodium lauryl sulfate
Also known as: Allegra
with sodium lauryl sulfate
Also known as: Allegra
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
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
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
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
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Each participant's data will be de-identified before it is shared with others who meet specified access criteria.
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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University of California, San Francisco