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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
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 May 25, 2017