Food Effect Study of Codeine Sulfate

Roxane Laboratories

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Codeine Sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009892

CODE-T60-PVFS/FD-1

Details and patient eligibility

About

The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate 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 Codeine Sulfate or any comparable or similar product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Codeine Sulfate, 30 mg

Active Comparator group

Description:

tablet

Treatment:

Drug: Codeine Sulfate

Codeine Sulfate, 60 mg

Active Comparator group

Description:

tablet

Treatment:

Drug: Codeine Sulfate

Codeine Sulfate, 15 mg

Active Comparator group

Description:

tablet

Treatment:

Drug: Codeine Sulfate