Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions
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ClinicalTrials.gov Identifier: NCT01010139 |
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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

- Drug: Codeine Sulfate
15 mg, 30 mg and 60 mg Tablet
- bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 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): NCT01010139
United States, Texas | |
CEDRA Clinical Research | |
San Antonio, Texas, United States, 78217 |
Principal Investigator: | James P Doherty, DO | CEDRA Clinical Research |
Responsible Party: | Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT01010139 |
Other Study ID Numbers: |
CODE-T60-PLFS-1 |
First Posted: | November 9, 2009 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Codeine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |