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Completed

NCT Number: NCT01332578

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

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.

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Key information

Conditions

Influenza Common Cold Infections Influenza, Human Orthomyxoviridae Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

BIO-IMAGES Research Ltd.

Glasgow, Scotland, G63 0BX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

Present in both test and active comparator

Phenylephrine

Drug

Test product

ascorbic acid

Drug

Test product

Primary outcomes

  1. Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)

    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

    Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.

Secondary outcomes

  1. Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)

    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 (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule.

  2. AUC (0-60 Min)

    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) was determined from paracetamol plasma concentration time profiles using trapezoidal method.

  3. Maximum Plasma Concentration (Cmax)

    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

    Cmax was determined using plasma paracetamol concentration time profile.

  4. Time to Maximum Plasma Concentration (Tmax)

    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 after administration when the maximum plasma concentration was reached.

  5. Time to Onset of Gastric Emptying

    Time frame: Baseline to 10 hours

    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.

  6. Time to Completion of Gastric Emptying

    Time frame: Baseline to 10 hours

    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.

  7. Time to Onset and Completion of Disintegration of Reference Tablets

    Time frame: Baseline to 10 hours post dose

    Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 11, 2011
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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