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NCT00759915 · ClinicalTrials.gov registry record · Phase 1
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
A Phase 1 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00759915: Completed Phase 1 study, sponsored by Actavis.
NCT00759915 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00759915, a Phase 1 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma Branded Products Inc.. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.
Interventions
- DRUG morphine sulfate extended-release capsules
- DRUG KADIAN (morphine sulfate extended-release) capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-08 |
| Est. Completion | 2006-10 |
| Phase | Phase 1 |
What the finished NCT00759915 record still lists
NCT00759915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which morphine sulfate extended-release capsules is the first listed.
NCT00759915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00759915 about?
NCT00759915 is a clinical study titled "Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions". The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the commercially available reference produ...
What is the current status of trial NCT00759915?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2006-08. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00759915?
The interventions under investigation include: morphine sulfate extended-release capsules (DRUG), KADIAN (morphine sulfate extended-release) capsules (DRUG).
Who is sponsoring clinical trial NCT00759915?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00759915's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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