NCT04534153

Excipient Effect on Drug Absorption in Humans

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• The Impact of Excipients on Drug Absorption

Interventions

Type	Name	Description
DRUG	Fexofenadine Hydrochloride without sodium lauryl sulfate	without sodium lauryl sulfate
DRUG	Fexofenadine Hydrochloride with sodium lauryl sulfate	with sodium lauryl sulfate

Timeline

• Start date: 2023-01-31
• Primary completion: 2025-06-18
• Completion: 2025-08-18
• First posted: 2020-09-01
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study