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NCT01432561 · ClinicalTrials.gov registry record · NA
Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01432561 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 8 participants.
The verdict
NCT01432561, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the rare disease cystinosis that became available in 1994, but there is inadequate knowledge of the food-effect on this drug's bioavailability. This study aims to investigate how food affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.
Interventions
- DRUG Cysteamine bitartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01432561
The ClinicalTrials.gov registry entry for NCT01432561 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cysteamine bitartrate is the first listed.
NCT01432561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01432561 about?
NCT01432561 is a clinical study titled "Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™". In order to meet FDA standards of safety and efficacy reporting for most new drugs, food-effect bioavailability (the impact that the presence of food in the digestive tract has on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the site of action) must be collec...
What is the current status of trial NCT01432561?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2011-09. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01432561?
The interventions under investigation include: Cysteamine bitartrate (DRUG).
Who is sponsoring clinical trial NCT01432561?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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