Phase 4
Completed N=25
A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
Influenza · Common Cold
Source: ClinicalTrials.gov NCT01332578 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter) — 4.59; 23.14 minutes — p=0.0004
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter) |
4.59; 23.14 | 0.0004 sig |
| SECONDARY Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min) |
1535.80; 387.28 | — |
| SECONDARY AUC (0-60 Min) |
5007.11; 1874.22 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) |
8309.58; 9225.20 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
1.50; 1.99 | — |
| SECONDARY Time to Onset of Gastric Emptying |
7.86; 54.23 | — |
| SECONDARY Time to Completion of Gastric Emptying |
202.59; 168.38 | — |
| SECONDARY Time to Onset and Completion of Disintegration of Reference Tablets |
42.50; 62.88 | — |
Eligibility Criteria
- Healthy male volunteers
- Body mass index between 18.0-29.9 kg/m^2
Data sourced from ClinicalTrials.gov (NCT01332578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.