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Last Updated: July 7, 2020

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CLINICAL TRIALS PROFILE FOR CODEINE SULFATE

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All Clinical Trials for Codeine Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01009697 Dose Linearity Study of Codeine Sulfate Under Fasted Conditions Completed Roxane Laboratories Phase 1 2008-03-01 The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions
NCT01009853 Steady State Study of Codeine Sulfate Completed Roxane Laboratories Phase 1 2008-01-01 Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.
NCT01009892 Food Effect Study of Codeine Sulfate Completed Roxane Laboratories Phase 1 2008-01-01 The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet
NCT01010139 Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions Completed Roxane Laboratories N/A 2006-08-01 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.
NCT01010152 Comparative Bioavailability Study of Codeine Sulfate Completed Roxane Laboratories Phase 1 2008-01-01 The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions
NCT01676493 A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain Terminated Quintiles, Inc. Phase 3 2012-08-01 This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Codeine Sulfate

Condition Name

Condition Name for Codeine Sulfate
Intervention Trials
Pain 6
Analgesia 1
Spinal Stenosis 1
Spinal Disease 1
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Condition MeSH

Condition MeSH for Codeine Sulfate
Intervention Trials
Spinal Stenosis 1
Spinal Diseases 1
Pain, Postoperative 1
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Clinical Trial Locations for Codeine Sulfate

Trials by Country

Trials by Country for Codeine Sulfate
Location Trials
United States 6
Brazil 1
Greece 1
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Trials by US State

Trials by US State for Codeine Sulfate
Location Trials
Texas 6
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Clinical Trial Progress for Codeine Sulfate

Clinical Trial Phase

Clinical Trial Phase for Codeine Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Codeine Sulfate
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 2
Terminated 1
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Clinical Trial Sponsors for Codeine Sulfate

Sponsor Name

Sponsor Name for Codeine Sulfate
Sponsor Trials
Roxane Laboratories 6
Aristotle University Of Thessaloniki 1
University of Sao Paulo General Hospital 1
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Sponsor Type

Sponsor Type for Codeine Sulfate
Sponsor Trials
Industry 7
Other 2
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Serving leading biopharmaceutical companies globally:

McKinsey
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