drugset / Trial / NCT02572375
Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study
RandomizedCrossoverSingle-blindTreatment
Summary
The objectives of this pivotal study are: 1. to evaluate bioavailability of an extended-release and immediate release Codeine Phosphate/Guaifenesin tablet at steady state following multiple oral administration 2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended release formulation.
Timeline
- Start
- 2014-10
- Primary completion
- 2014-11
- Completion
- 2015-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Codeine | Small molecule | 20 mg | Oral |
| Subject | Codeine | Small molecule | 60 mg | Oral |
| Subject | Guaifenesin | Small molecule | 400 mg | Oral |
| Subject | Guaifenesin | Small molecule | 1200 mg | Oral |
Indications
No indication recorded.