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NCT00853554 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets
A Phase 1 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00853554: Completed Phase 1 study, sponsored by Mallinckrodt.
NCT00853554 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853554, a Phase 1 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an equivalent oral dose of a commercially available hydromorphone tablet (DILAUDID® 8 mg, Knoll Pharmaceutical Company) in a test group of healthy subjects under fasting conditions.
Interventions
- DRUG Hydromorphone Hydrochloride tablet 8 mg
- DRUG Dilaudid® tablet 8 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2002-12 |
| Est. Completion | 2002-12 |
| Phase | Phase 1 |
What the finished NCT00853554 record still lists
NCT00853554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Hydromorphone Hydrochloride tablet 8 mg is the first listed.
NCT00853554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853554 about?
NCT00853554 is a clinical study titled "Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets". The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an equivalent oral dose of a commercially available hydromorphone tablet (DILAUDID® 8 mg, Knoll Pharmaceutical Company) ...
What is the current status of trial NCT00853554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2002-12. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00853554?
The interventions under investigation include: Hydromorphone Hydrochloride tablet 8 mg (DRUG), Dilaudid® tablet 8 mg (DRUG).
Who is sponsoring clinical trial NCT00853554?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853554's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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