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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 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 36 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00759915
The ClinicalTrials.gov registry entry for NCT00759915 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which morphine sulfate extended-release capsules is the first listed.
NCT00759915 reports 0 study locations.
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.
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