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 |
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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 | >Sponsor | >Phase | >Start Date | >Summary |
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