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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fexofenadine without SLS | Experimental | Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride and 101 mg microcrystalline cellulose |
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| Fexofenadine and 3 mg SLS | Experimental | Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 3 mg SLS and 101 mg microcrystalline cellulose |
|
| Fexofenadine and 30 mg SLS | Experimental | Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 30 mg SLS and 101 mg microcrystalline cellulose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine Hydrochloride without sodium lauryl sulfate | Drug | without sodium lauryl sulfate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 0-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sodium lauryl sulfate plasma concentration | To determine plasma SLS concentration in order to understand the absorption of SLS in humans | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Yang, PharmD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ucsf Ctsi Crc | San Francisco | California | 94143 | United States |
Each participant's data will be de-identified before it is shared with others who meet specified access criteria.
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Once after publication
De-identified specimens may be shared with other researchers so they can use them for, but not limited to, genomic, epigenetic, metabolomic, proteomic and transcriptomic follow-up studies.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2024 | Jun 27, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| C093230 | fexofenadine |
| D012967 | Sodium Dodecyl Sulfate |
| ID | Term |
|---|---|
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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This is a single-center, randomized, double-blind, 3-period crossover trial. Subjects will be randomized to receive fexofenadine only under Treatment Arm 1 or fexofenadine and 3 mg SLS under Treatment Arm 2 or fexofenadine and 30 mg SLS under Treatment Arm 3.
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| Fexofenadine Hydrochloride with sodium lauryl sulfate | Drug | with sodium lauryl sulfate |
|
|
| 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. | 0-48 hours |
| D000476 |
| Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |