MedPath

Comparative Bioavailability Study of Codeine Sulfate

Phase 1
Completed
Conditions
Pain
Interventions
Registration Number
NCT01010152
Lead Sponsor
Roxane Laboratories
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Tylenol #3Codeine Sulfate30 mg tablet
Codeine SulfateCodeine Sulfate30 mg tablet
Primary Outcome Measures
NameTimeMethod
bioequivalence determined by statistical comparison Cmax15 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CEDRA Clinical Research LLC

🇺🇸

San Antonio, Texas, United States

CEDRA Clinical Research LLC
🇺🇸San Antonio, Texas, United States
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