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

Roxane Laboratories

Status: Completed

Conditions: Pain

Treatments: Drug: morphine sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994942

MORP-T30-PLFS-1

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)