Food Effect Study of Codeine Sulfate
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01009892
Collaborator
(none)
36
1
3
Study Details
Study Description
Brief Summary
The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions
Study Start Date
:
Jan 1, 2008
Actual Primary Completion Date
:
Jan 1, 2008
Actual Study Completion Date
:
Jan 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Codeine Sulfate, 30 mg tablet |
Drug: Codeine Sulfate
Tablet
|
| Active Comparator: Codeine Sulfate, 60 mg tablet |
Drug: Codeine Sulfate
Tablet
|
| Active Comparator: Codeine Sulfate, 15 mg tablet |
Drug: Codeine Sulfate
Tablet
|
Outcome Measures
Primary Outcome Measures
- bioequivalence determined by statistical comparison Cmax [8 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CEDRA Clinical Research | San Antonio | Texas | United States | 78217 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: Fredrick Bieberdorf, CEDRA Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01009892
Other Study ID Numbers:
- CODE-T60-PVFS/FD-1
First Posted:
Nov 9, 2009
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018
Additional relevant MeSH terms: