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NCT03717129 · ClinicalTrials.gov registry record · Phase 4
Analysis of Crushed and Whole Tablet Genvoya
A Phase 4 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT03717129: Completed Phase 4 study, sponsored by Johns Hopkins University.
NCT03717129 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03717129, a Phase 4 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet. The first study sequence will involve a directly observed single dose of the fixed dose formulation of whole Genvoya tablet, with semi-intensive pharmacokinetic serum sampling at time points following the dose. After a washout period of seven days, subjects will then receive a directly observed single dose of a crushed tablet of Genvoya with subsequent semi-intensive pharmacokinetic serum sampling.
Interventions
- DRUG Genvoya Oral dose
- DRUG Genvoya Crushed Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03717129
The ClinicalTrials.gov registry entry for NCT03717129 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Genvoya Oral dose is the first listed.
NCT03717129 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03717129 about?
NCT03717129 is a clinical study titled "Analysis of Crushed and Whole Tablet Genvoya". Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet. The first study sequence will involve a directly observed single dose of the fixed dose formulation of whole Genvoya tablet, wit...
What is the current status of trial NCT03717129?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2019-04-15. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT03717129?
The interventions under investigation include: Genvoya Oral dose (DRUG), Genvoya Crushed Dose (DRUG).
Who is sponsoring clinical trial NCT03717129?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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