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

Roxane Laboratories18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

morphine sulfateDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CEDRA Clinical Research

Austin, Texas, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 7 days

Data from ClinicalTrials.gov

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