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Excipient Impact on Drug Absorption

Phase < 1
Recruiting
Led By Kathleen M Giacomini, Ph.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and females between the ages of 18-64 years old, inclusive
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-48 hours
Awards & highlights

Study Summary

This trial will compare how well drugs are absorbed when taken with different amounts of sodium lauryl sulfate.

Who is the study for?
Healthy adults aged 18-64, willing to avoid certain fruit juices and supplements, can join this trial. They must not be extremely obese, allergic to the drug or its components, have low hemoglobin levels, be pregnant/breastfeeding without birth control use, or have liver/kidney/heart diseases.Check my eligibility
What is being tested?
The study is testing how a common non-drug ingredient called sodium lauryl sulfate (SLS) affects the absorption of Fexofenadine Hydrochloride. Participants will take the drug with varying amounts of SLS to see if there's any difference in how well their body absorbs it.See study design
What are the potential side effects?
While specific side effects are not listed for this trial scenario since it involves healthy volunteers and a commonly used medication component (SLS), typical reactions might include digestive discomfort or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration versus time curve (AUC) of Fexofenadine
Maximum Plasma Concentration (Cmax) of Fexofenadine
Secondary outcome measures
Fexofenadine stool amount
Sodium lauryl sulfate plasma concentration
Sodium lauryl sulfate stool amount

Trial Design

3Treatment groups
Experimental Treatment
Group I: Fexofenadine without SLSExperimental Treatment1 Intervention
Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride and 101 mg microcrystalline cellulose
Group II: Fexofenadine and 30 mg SLSExperimental Treatment1 Intervention
Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 30 mg SLS and 101 mg microcrystalline cellulose
Group III: Fexofenadine and 3 mg SLSExperimental Treatment1 Intervention
Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 3 mg SLS and 101 mg microcrystalline cellulose

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Excipients, such as sodium lauryl sulfate (SLS), play a crucial role in drug absorption by modifying the drug's solubility and permeability. SLS, a surfactant, can enhance the absorption of drugs by reducing surface tension and increasing the wettability of the drug particles, thereby improving their dissolution rate. This is particularly important for drugs with poor water solubility, as it can significantly impact their bioavailability and therapeutic efficacy. Understanding the role of excipients like SLS is essential for optimizing drug formulations to ensure consistent and effective drug delivery for patients.
Comparison of dissolution profiles and serum concentrations of two lamotrigine tablet formulations.Enhancement of heparin and heparin disaccharide absorption by the Phytolacca americana saponins.Targeted delivery of salicylic acid from acne treatment products into and through skin: role of solution and ingredient properties and relationships to irritation.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,527 Previous Clinical Trials
15,242,588 Total Patients Enrolled
Food and Drug Administration (FDA)FED
174 Previous Clinical Trials
1,333,680 Total Patients Enrolled
Kathleen M Giacomini, Ph.D.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
20 Total Patients Enrolled
~5 spots leftby Aug 2025