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A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.

NCT ID: NCT01551797

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

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This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Sustained Release (SR) Paracetamol (2000 mg)

A single 2000 mg oral dose of SR paracetamol formulation (2 x 1000 mg) administered with 150 mL of water.

Group Type EXPERIMENTAL

Paracetamol 1000 mg

Intervention Type DRUG

Paracetamol Sustained Release formulation

Test SR Paracetamol (1500 mg)

A single 1500 mg oral dose of SR paracetamol formulation (2 x 750 mg) administered with 150 mL of water.

Group Type EXPERIMENTAL

Paracetamol 750 mg

Intervention Type DRUG

Paracetamol Sustained Release formulation

Reference Paracetamol (2000 mg)

Two single 1000 mg doses of paracetamol (2 x 500 mg/dose) administered orally 6 hours apart, administered with 150 mL of water.

Group Type ACTIVE_COMPARATOR

Paracetamol 500 mg

Intervention Type DRUG

Standard Paracetamol formulation

Interventions

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Paracetamol 500 mg

Standard Paracetamol formulation

Intervention Type DRUG

Paracetamol 1000 mg

Paracetamol Sustained Release formulation

Intervention Type DRUG

Paracetamol 750 mg

Paracetamol Sustained Release formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

Exclusion Criteria

* Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
* Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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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Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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A2750894

Identifier Type: -

Identifier Source: org_study_id