A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
Summary
The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.
Timeline
- Start
- 2011-05
- Primary completion
- 2011-06
- Completion
- 2011-06
Outcome
Met primary endpoint
registry analysis (superiority or other test); Hot Drink Remedy vs Standard Paracetamol Tablets; p = 0.0004; Median Difference (Final Values) -20.92 (95% CI -27.31 to -15.81); Wilcoxon (Mann-Whitney) NCT01332578 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1000 mg | Oral |
| Background | Phenylephrine | Small molecule | — | Oral |
| Background | Vitamin C | Other / unclassified | — | Oral |