Pharmacokinetic Study to Compare Two Formulations of Paracetamol

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-04-30

Brief Summary

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A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.

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Detailed Description

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Conditions

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Fever Headache Disorders 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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Experimental Paracetamol Tablet

Experimental paracetamol tablet (500 milligrams \[mg\]) administered with 240 milliliters (mL) of water.

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

500 mg immediate release paracetamol formulations

Standard Paracetamol Tablet (500 mg)

Standard paracetamol tablet (500 mg) administered with 240 mL of water.

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

500 mg immediate release paracetamol formulations

Interventions

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Paracetamol

500 mg immediate release paracetamol formulations

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
* BMI must be within the range 18.5 - 24.9 kg/m\^2
* Participant with a minimum weight of 50 kg

Exclusion Criteria

* Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
* Participant with known or suspected intolerance or hypersensitivity to the study materials
* Participant who are vegetarian
* Participant smoking more than five cigarettes a day

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes