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

NCT ID: NCT01332578

Last Updated: 2015-06-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Influenza Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Test Product

Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

Present in both test and active comparator

Phenylephrine

Intervention Type DRUG

Test product

Ascorbic Acid

Intervention Type DRUG

Test product

Paracetamol tablet

Two paracetamol 500 mg tablets to be administered with 150 mL of hot water.

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Present in both test and active comparator

Interventions

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Paracetamol

Present in both test and active comparator

Intervention Type DRUG

Phenylephrine

Test product

Intervention Type DRUG

Ascorbic Acid

Test product

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers
* Body mass index between 18.0-29.9 kg/m\^2
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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BIO-IMAGES Research Ltd.

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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C7591227

Identifier Type: -

Identifier Source: org_study_id

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