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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 7, 2011
Last updated: November 8, 2012
Last verified: November 2012

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.

Condition Intervention Phase
Common Cold
Drug: Paracetamol
Drug: Phenylephrine
Drug: Ascorbic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to reach plasma paracetamol concentration of 0.25 ug/ml (t0.25ug/ml) [ Time Frame: up to 3 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve (AUC0-30 min) [ Time Frame: up to 30 minutes post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC0-60 min) [ Time Frame: up to 60 minutes post dose ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) [ Time Frame: up to 3 hour post dose ] [ Designated as safety issue: No ]
  • Time to Cmax [ Time Frame: up to 3 hours post dose ] [ Designated as safety issue: No ]
  • Plasma concentrations of paracetamol [ Time Frame: up to 3 hours post dose ] [ Designated as safety issue: No ]
  • Scintigraphic measurement-time to onset and gastric emptying [ Time Frame: up to 10 hours post dose ] [ Designated as safety issue: No ]
  • Time and site of onset and complet disintegration of tablets [ Time Frame: up to 10 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Product
Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.
Drug: Paracetamol
Present in both test and active comparator
Drug: Phenylephrine
Test product
Drug: Ascorbic Acid
Test product
Active Comparator: Paracetamol tablet
Two paracetamol 500 mg tablets to be administered with 150 mL of hot water.
Drug: Paracetamol
Present in both test and active comparator


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
  • Healthy male volunteers
  • Body mass index between 18.0-29.9 kg/m^2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332578

United Kingdom
BIO-IMAGES Research Ltd.
Glasgow, Scotland, United Kingdom, G63 0BX
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332578     History of Changes
Other Study ID Numbers: C7591227
Study First Received: April 7, 2011
Last Updated: November 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Common Cold
Influenza, Human
Orthomyxoviridae Infections
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Ascorbic Acid
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Growth Substances
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 29, 2015