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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332578
First received: April 7, 2011
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Influenza
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • Healthy male volunteers
  • Body mass index between 18.0-29.9 kg/m^2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332578

Locations
United Kingdom
BIO-IMAGES Research Ltd.
Glasgow, Scotland, United Kingdom, G63 0BX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Orthomyxoviridae Infections
Acetaminophen
Phenylephrine
Oxymetazoline
Ascorbic Acid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on June 17, 2013