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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332578
• Other study ID #: C7591227
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2011
• Last updated: May 28, 2015
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

• Healthy male volunteers

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Common Cold
• Influenza
• Influenza, Human

Intervention

Drug:
• Paracetamol
Present in both test and active comparator
• Phenylephrine
Test product
• Ascorbic Acid
Test product

Locations

Country	Name	City	State
United Kingdom	BIO-IMAGES Research Ltd.	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Reach Plasma Paracetamol Concentration of 0.25 µg/mL (Microgram Per Milliliter)	Time to reach plasma paracetamol concentration of 0.25 µg/mL was determined using plasma concentration time profiles.	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	No
Secondary	Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)	AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule.	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	No
Secondary	AUC (0-60 Min)	AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method.	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	No
Secondary	Maximum Plasma Concentration (Cmax)	Cmax was determined using plasma paracetamol concentration time profile.	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	No
Secondary	Time to Maximum Plasma Concentration (Tmax)	Time after administration when the maximum plasma concentration was reached.	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	No
Secondary	Time to Onset of Gastric Emptying	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.	Baseline to 10 hours	No
Secondary	Time to Completion of Gastric Emptying	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.	Baseline to 10 hours	No
Secondary	Time to Onset and Completion of Disintegration of Reference Tablets	Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.	Baseline to 10 hours post dose	No