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NCT01448772 · ClinicalTrials.gov registry record · Phase 1
Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT01448772: Completed Phase 1 study, sponsored by INSYS Therapeutics.
NCT01448772 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 88 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01448772, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.
Primary Outcome
The plasma concentration versus time data of dronabinol and its metabolite (11-hydroxy-delta-9-tetrahydrocannabinol) will be analyzed. The PK parameters Cmax, AUC0-t and AUCinf for delta-9-tetrahydrocannabinol will be calculated and used as the measures for comparative bioavailability assessment of dronabinol oral solution versus the innovator capsule product.
Interventions
- DRUG Dronabinol Capsules, 5 mg
- DRUG Dronabinol Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2011-10 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT01448772 record still lists
NCT01448772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Dronabinol Capsules, 5 mg is the first listed.
NCT01448772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01448772 about?
NCT01448772 is a clinical study titled "Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions". This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.
What is the current status of trial NCT01448772?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2011-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01448772?
The interventions under investigation include: Dronabinol Capsules, 5 mg (DRUG), Dronabinol Oral Solution (DRUG).
Who is sponsoring clinical trial NCT01448772?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01448772's enrollment target sits among peer trials
88 650th of 2000 higher than 1,350 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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