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

Phase 4

Completed

• Conditions: Influenza; Common Cold
• Interventions: Drug: Paracetamol; Drug: Phenylephrine; Drug: Ascorbic Acid

• Registration Number: NCT01332578
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Study Start: 2011-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-07-18
• Status Verified: 2015-04
• Results First Submitted QC: 2015-05-28
• Last Update Submitted: 2015-05-28
• Results First Posted: 2015-06-01
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Paracetamol tablet	Paracetamol	Two paracetamol 500 mg tablets to be administered with 150 mL of hot water.
Test Product	Phenylephrine	Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.
Test Product	Ascorbic Acid	Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.
Test Product	Paracetamol	Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.

Primary Outcome Measures

Name	Time	Method
Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)	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 Outcome Measures

Name	Time	Method
Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)	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.
AUC (0-60 Min)	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.
Maximum Plasma Concentration (Cmax)	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.
Time to Maximum Plasma Concentration (Tmax)	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.
Time to Onset of Gastric Emptying	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.
Time to Completion of Gastric Emptying	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.
Time to Onset and Completion of Disintegration of Reference Tablets	Baseline to 10 hours post dose	Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.

Trial Locations

Locations (1)

BIO-IMAGES Research Ltd.; 🇬🇧 Glasgow, Scotland, United Kingdom