drugset / Trial / NCT00973232
A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
RandomizedCrossoverOpen-label
Summary
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation.
Timeline
- Start
- 2008-05
- Primary completion
- 2008-08
- Completion
- 2008-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 650 mg | Oral |
| Subject | Acetaminophen | Small molecule | 1300 mg | Oral |
| Subject | Tramadol | Other / unclassified | 75 mg | Oral |
| Subject | Tramadol | Other / unclassified | 150 mg | Oral |
Indications
No indication recorded.