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Last Updated: October 12, 2024

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 2012-04-01 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
Spinal Stenosis 1
Analgesia 1
Cholecystectomy 1
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Condition MeSH

Condition MeSH for Codeine Sulfate
Intervention Trials
Pain, Procedural 1
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
Greece 1
Brazil 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
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
Quintiles, Inc. 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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