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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994942

Enrollment

Registered

2009-10-14

Start date

2006-04-30

Completion date

2006-04-30

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

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

Interventions

DRUGmorphine sulfate

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

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	7 days

Countries

United States

Outcome results

None listed

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