Conditions: Influenza Common Cold
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water. arm 2: Two paracetamol 500 mg tablets to be administered with 150 mL of hot water.

Interventions: intervention 1: Paracetamol intervention 2: Phenylephrine intervention 3: Ascorbic Acid
Intervention descriptions: intervention 1: Present in both test and active comparator intervention 2: Test product intervention 3: Test product

Protocol document: