Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions

Determine the pharmacokinetics and optimize study design for subsequent studies with morphine sulfate tablets and solution.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEDRA Clinical Research

Austin, Texas, 78759, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine sulfate

Drug

morphine sulfate 30 mg tablet, morphine sulfate 30 mg (10 mg / 5 mL) oral solution, morphine sulfate injection 10 mg (1 mg / mL)

Other names: DURAMORPH

Primary outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Pharmacokinetic and Comparative Bioavailability Study of Morphine Sulfate Injection, Solution, and Tablet Formulations Under Fasting Conditions.

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Oct 14, 2009
Registry last updated: Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed