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Excipient Effect on Drug Absorption in Humans

NCT04534153 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-18

No results posted yet for this 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.

Conditions

  • The Impact of Excipients on Drug Absorption

Interventions

DRUG

Fexofenadine Hydrochloride without sodium lauryl sulfate

without sodium lauryl sulfate

DRUG

Fexofenadine Hydrochloride with sodium lauryl sulfate

with sodium lauryl sulfate

Sponsors & Collaborators

Principal Investigators

  • Katherine Yang, PharmD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-06-18
Completion
2025-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534153 on ClinicalTrials.gov