Dose Proportionality and Food Effect of Morphine Sulfate

Roxane Laboratories

Status: Completed

Conditions: Pain

Treatments: Drug: morphine sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994539

MORP-T30-PVFS-2

Details and patient eligibility

About

Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.

Enrollment: 36 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)