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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). 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.
Primary Outcome
AUC 0 to Infinity for Elvitegravir (ng\*h/mL)
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 |
What the finished NCT03717129 record still lists
NCT03717129 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Genvoya Oral dose is the first listed.
NCT03717129 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03717129's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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