Comparative Bioavailability 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

NCT01010152

CODE-T30-PVFS-1

Details and patient eligibility

About

The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions

Enrollment: 34 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)

---

34 participants in 2 patient groups

Codeine Sulfate

Experimental group

Description:

30 mg tablet

Treatment:

Drug: Codeine Sulfate

Tylenol #3

Active Comparator group

Description:

30 mg tablet

Treatment:

Drug: Codeine Sulfate