Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions
This study has been completed.
Sponsor:
Roxane Laboratories
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01010139
First received: November 6, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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Purpose
The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.
| Condition | Intervention |
|---|---|
|
Pain |
Drug: Codeine Sulfate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Roxane Laboratories:
Primary Outcome Measures:
- bioequivalence determined by statistical comparison Cmax [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | August 2006 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Codeine Sulfate
15 mg, 30 mg and 60 mg Tablet
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01010139
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010139
Locations
| United States, Texas | |
| CEDRA Clinical Research | |
| San Antonio, Texas, United States, 78217 | |
Sponsors and Collaborators
Roxane Laboratories
Investigators
| Principal Investigator: | James P Doherty, DO | CEDRA Clinical Research |
More Information
| Responsible Party: | Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT01010139 History of Changes |
| Other Study ID Numbers: | CODE-T60-PLFS-1 |
| Study First Received: | November 6, 2009 |
| Last Updated: | November 6, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 30, 2016