Excipient Impact on Drug Absorption
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if adding sodium lauryl sulfate (SLS) to fexofenadine changes how well the drug works. It looks at people taking fexofenadine and checks drug levels in the blood and stool to see if SLS makes a difference. SLS has been shown to help various substances get into the body better.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any drugs, especially those known as OATP2B1 substrates, except for birth control hormonal medications.
Is sodium lauryl sulfate (SLS) safe for human use in drug formulations?
Sodium lauryl sulfate (SLS) is commonly used in drug formulations, but it can reduce cell viability and alter the barrier integrity of the gut lining in lab and animal studies. Some research suggests it may be linked to conditions like ulcerative colitis and metabolic disorders, so its safety in humans should be carefully considered.12345
How does the drug sodium lauryl sulfate affect drug absorption?
Sodium lauryl sulfate (SLS) is unique because it can enhance the passive absorption of drugs by altering the intestinal membrane's permeability, making it easier for drugs to pass through. This effect is particularly notable when the drug's carrier-mediated transport is saturated, leading to increased absorption rates.26789
What data supports the effectiveness of the drug Sodium Lauryl Sulfate on drug absorption?
Research shows that Sodium Lauryl Sulfate can enhance the absorption of certain drugs, like cefadroxil, by increasing their passive absorption in the intestines. However, it can also reduce the absorption of other drugs, like ritonavir, in acidic environments due to the formation of poorly soluble salts.1281011
Who Is on the Research Team?
Katherine Yang, PharmD, MPH
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fexofenadine with or without sodium lauryl sulfate in a 3-period crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Excipient Effect on Drug Absorption
- Sodium Lauryl Sulfate
Excipient Effect on Drug Absorption is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Approved as an excipient in various medicinal products
- Approved as an inactive ingredient in various drug products
- Approved as a non-medicinal ingredient in various drug products
- Approved as an excipient in various medicinal products
- Approved as an excipient in various medicinal products
- Approved as an excipient in various medicinal products
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Food and Drug Administration (FDA)
Collaborator