drugset / Trial / NCT02157649
Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin
RandomizedCrossoverOpen-labelTreatment
Summary
The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.
Timeline
- Start
- 2014-06
- Primary completion
- 2014-08
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Codeine | Small molecule | 20 mg | — |
| Comparator | Codeine | Small molecule | 30 mg | — |
| Comparator | Guaifenesin | Small molecule | 400 mg | — |
| Comparator | Guaifenesin | Small molecule | 600 mg | — |
Indications
No indication recorded.