Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

Roxane Laboratories18 enrolled

Overview

The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Codeine SulfateDRUG

15 mg, 30 mg and 60 mg Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CEDRA Clinical Research

San Antonio, Texas, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 21 Days

Data from ClinicalTrials.gov

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