Comparative Bioavailability Study of Codeine Sulfate
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ClinicalTrials.gov Identifier: NCT01010152 |
Recruitment Status :
Completed
First Posted : November 9, 2009
Last Update Posted : January 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: Codeine Sulfate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 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 Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting Conditions |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Codeine Sulfate
30 mg tablet
|
Drug: Codeine Sulfate
30 mg Tablet
Other Name: Tylenol #3 Tablets |
Active Comparator: Tylenol #3
30 mg tablet
|
Drug: Codeine Sulfate
30 mg Tablet
Other Name: Tylenol #3 Tablets |
- bioequivalence determined by statistical comparison Cmax [ Time Frame: 15 days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010152
United States, Texas | |
CEDRA Clinical Research LLC | |
San Antonio, Texas, United States, 78217 |
Principal Investigator: | Fredrick Bieberdorf, M.D. | CEDRA Clinical Research |
Responsible Party: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT01010152 |
Other Study ID Numbers: |
CODE-T30-PVFS-1 |
First Posted: | November 9, 2009 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Codeine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Analgesics, Opioid Narcotics Central Nervous System Depressants Antitussive Agents Respiratory System Agents |