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Steady State Study of Codeine Sulfate

NCT01009853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-01-23

No results posted yet for this study

Summary

Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.

Conditions

Interventions

DRUG

Codeine Sulfate

15 mg tablet

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Fredrick Bieberdorf, MD · CEDRA Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01009853 on ClinicalTrials.gov