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NCT01452542 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of the Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01452542 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 22 participants.
The verdict
NCT01452542, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary objective of this pilot study is to determine the within-subject pharmacokinetic (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to plan and support the design of a subsequent bioequivalence study.
Interventions
- DRUG Eliglustat, common blend proposed commercial formulation
- DRUG Eliglustat, Phase 3 capsule formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-10 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01452542
The ClinicalTrials.gov registry entry for NCT01452542 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Eliglustat, common blend proposed commercial formulation is the first listed.
NCT01452542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01452542 about?
NCT01452542 is a clinical study titled "A Phase I Study of the Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects". The primary objective of this pilot study is to determine the within-subject pharmacokinetic (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed commercial formulation (1x150-...
What is the current status of trial NCT01452542?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-10. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01452542?
The interventions under investigation include: Eliglustat, common blend proposed commercial formulation (DRUG), Eliglustat, Phase 3 capsule formulation (DRUG).
Who is sponsoring clinical trial NCT01452542?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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