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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Influenza; Common Cold

Treatments: Drug: Ascorbic Acid; Drug: Paracetamol; Drug: Phenylephrine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332578

C7591227

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Healthy male volunteers
• Body mass index between 18.0-29.9 kg/m^2

Trial design

25 participants in 2 patient groups

Test Product

Experimental group

Description:

Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.

Treatment:

Drug: Phenylephrine

Drug: Paracetamol

Drug: Ascorbic Acid

Paracetamol tablet

Active Comparator group

Description:

Two paracetamol 500 mg tablets to be administered with 150 mL of hot water.

Treatment:

Drug: Paracetamol