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NCT04534153 · ClinicalTrials.gov registry record · Early Phase 1
Excipient Effect on Drug Absorption in Humans
A Early Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT04534153: Completed Early Phase 1 study, sponsored by University of California, San Francisco.
NCT04534153 is a Early Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534153, a Early Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DRUG Fexofenadine Hydrochloride without sodium lauryl sulfate
- DRUG Fexofenadine Hydrochloride with sodium lauryl sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2025-08-18 |
| Phase | Early Phase 1 |
What the finished NCT04534153 record still lists
NCT04534153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Fexofenadine Hydrochloride without sodium lauryl sulfate is the first listed.
NCT04534153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534153 about?
NCT04534153 is a clinical study titled "Excipient Effect on Drug Absorption in Humans". 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 comp...
What is the current status of trial NCT04534153?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2023-01-31. Estimated completion is 2025-08-18.
What interventions are being tested in trial NCT04534153?
The interventions under investigation include: Fexofenadine Hydrochloride without sodium lauryl sulfate (DRUG), Fexofenadine Hydrochloride with sodium lauryl sulfate (DRUG).
Who is sponsoring clinical trial NCT04534153?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534153's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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