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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 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00853554
The ClinicalTrials.gov registry entry for NCT00853554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hydromorphone Hydrochloride tablet 8 mg is the first listed.
NCT00853554 reports 0 study locations.
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.
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