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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
25
Present in both test and active comparator
Test product
Test product
BIO-IMAGES Research Ltd.
Glasgow, Scotland, United Kingdom
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline to 10 hours post dose