Last updated: 11/04/2018 05:48:06

A comparison of solid and soluble forms of cold and influenza remedies

GSK study ID
C7591227
See study documents
Clinicaltrials.gov ID
NCT01332578
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A comparison of solid and soluble forms of cold and influenza remedies
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Time to reach plasma paracetamol concentration of 0.25 μg/mL (microgram per milliliter)

Timeframe: 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

Secondary outcomes:

Area under the concentration/time curve from 0 to 30 minutes (min) (AUC 0-30 min)

Timeframe: 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)

Timeframe: 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

Maximum Plasma Concentration (Cmax)

Timeframe: 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 to maximum plasma concentration (Tmax)

Timeframe: 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 to onset of gastric emptying

Timeframe: Baseline to 10 hours

Time to completion of Gastric Emptying

Timeframe: Baseline to 10 hours

Time to onset and completion of disintegration of reference tablets

Timeframe: Baseline to 10 hours post dose

Interventions:
Drug: Paracetamol
Drug: Phenylephrine
Drug: Ascorbic Acid
Enrollment:
25
Observational study model:
Not applicable
Primary completion date:
2011-30-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza, Common cold
Product
paracetamol
Collaborators
Not applicable
Study date(s)
May 2011 to June 2011
Type
Interventional
Phase
4

Participation criteria

Sex
Male
Age
18+ years
Accepts healthy volunteers
Yes
  • Healthy male volunteers
  • Body mass index between 18.0-29.9 kg/m^2
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy male volunteers
  • Body mass index between 18.0-29.9 kg/m^2

Trial location(s)

Location
Status
Contact us
Contact us
Location
BIO-IMAGES Research Ltd.
Glasgow, Scotland, United Kingdom, G63 0BX
Status
Study Complete
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2011-30-06
Actual study completion date
2011-30-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website