CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
morphine sulfate sustained-release capsules +1 moredrug
Likely dose
morphine sulfate sustained-release capsules 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00759356
NCT00759356Phase 1Completed
CompareCT.gov

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study Comparing the Bioavailability of a Morphine Sulfate Sustained Release Capsule 1 x 200mg to KADIAN 2 x 100mg Capsules Under Fed Conditions

Actavis Inc.·interventional·Posted Sep 25, 2008·Updated Aug 17, 2010

In Brief

A Phase 1 clinical trial evaluating morphine sulfate sustained-release capsules and KADIAN for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x 100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 25, 2008
Enrollment StartAug 1, 2004
Primary CompletionSep 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.8 years ago

Interventions

morphine sulfate sustained-release capsulesdrug

1 x 200 mg, single-dose capsule

KADIANdrug

2 x 100 mg, single-dose capsule