Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release

A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Comparative Bioavailability Study of Morphine Sulfate Immediate Release Tablets and Solution and Controlled Release Capsules Under Steady-State Conditions.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994383

Enrollment

Registered

2009-10-14

Start date

2007-01-31

Completion date

2007-01-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

Characterize the steady-state pharmacokinetics of morphine after oral administration of Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to compare their pharmacokinetics to that of AVINZA.

Interventions

DRUGmorphine sulfate

morphine sulfate 30 mg tablet, morphine sulfate 15 mg tablet, morphine sulfate controlled release 120 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

* Positive test for HIV, Hepatitis B, or Hepatitis C. * Treatment with known enzyme altering drugs. * History of allergic or adverse response to morphine sulfate or any comparable or similar product.

Design outcomes

Primary

Measure	Time frame
bioequivalence determined by statistical comparison Cmax	15 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026