drugset / Trial / NCT02465866
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
RandomizedCrossoverOpen-labelBasic science
Summary
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-04
- Completion
- 2015-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CL-108 | Unknown | 7.5 mg | Oral |
| Subject | CL-108 | Unknown | 12.5 mg | Oral |
| Subject | CL-108 | Unknown | 325 mg | Oral |
| Comparator | Promethazine | Small molecule | 12.5 mg | Oral |
| Comparator | Ultracet | Unknown | 37.5 mg | Oral |
| Comparator | Ultracet | Unknown | 325 mg | Oral |
| Comparator | Vicoprofen | Unknown | 7.5 mg | Oral |
| Comparator | Vicoprofen | Unknown | 200 mg | Oral |
Indications
No indication recorded.