NCT01010152

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

November 6, 2009

Last Update Submit

January 19, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    15 days

Study Arms (2)

Codeine Sulfate

EXPERIMENTAL

30 mg tablet

Drug: Codeine Sulfate

Tylenol #3

ACTIVE COMPARATOR

30 mg tablet

Drug: Codeine Sulfate

Interventions

Codeine SulfateDRUG

30 mg Tablet

Also known as: Tylenol #3 Tablets
Codeine SulfateTylenol #3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEDRA Clinical Research LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Pain

Interventions

O(6)-codeine methyl ether

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fredrick Bieberdorf, M.D.

    CEDRA Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)