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NCT00759759 · ClinicalTrials.gov registry record · Phase 1

Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions

A Phase 1 study of Healthy, sponsored by Actavis.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT00759759 is a Phase 1 study of Healthy that has completed, run by Actavis. The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00759759, a Phase 1 study of Healthy, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study 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 after a 10-hour overnight fast.

Conditions Studied

Interventions

  • DRUG morphine sulfate sustained-release capsules
  • DRUG KADIAN (morphine sulfate sustained-release) capsules

Study Locations (1)

Texas

  • CEDRA Clinical Research, LLC - Austin

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2004-09
Est. Completion 2004-10
Phase Phase 1

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT00759759

The ClinicalTrials.gov registry entry for NCT00759759 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, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which morphine sulfate sustained-release capsules is the first listed.

NCT00759759 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00759759 about?

NCT00759759 is a clinical study titled "Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions". 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 or...

What is the current status of trial NCT00759759?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2004-09. Estimated completion is 2004-10.

What conditions does trial NCT00759759 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00759759?

The interventions under investigation include: morphine sulfate sustained-release capsules (DRUG), KADIAN (morphine sulfate sustained-release) capsules (DRUG).

Who is sponsoring clinical trial NCT00759759?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00759759 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.