A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

Conditions
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Influenza, Common Cold

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Phenylephrine
* Drug: Ascorbic Acid


Participation Criteria
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Eligibility Criteria
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Healthy male volunteers Body mass index between 18.0-29.9 kg/m^2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water. | Drug: Paracetamol<br>* Present in both test and active comparator<br>Drug: Phenylephrine<br>* Test product<br>Drug: Ascorbic Acid<br>* Test product<br>|
| Active Comparator: Paracetamol tablet<br>Two paracetamol 500 mg tablets to be administered with 150 mL of hot water. | Drug: Paracetamol<br>* Present in both test and active comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter) | Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles. | Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min) | AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule. | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose | 
| AUC (0-60 Min) | AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method. | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose | 
| Maximum Plasma Concentration (Cmax) | Cmax was determined using plasma paracetamol concentration time profile. | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose | 
| Time to Maximum Plasma Concentration (Tmax) | Time after administration when the maximum plasma concentration was reached. | Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose | 
| Time to Onset of Gastric Emptying | The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets. | Baseline to 10 hours | 
| Time to Completion of Gastric Emptying | Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity. | Baseline to 10 hours | 
| Time to Onset and Completion of Disintegration of Reference Tablets | Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program. | Baseline to 10 hours post dose |