Pharmacokinetic Study to Compare Two Formulations of Paracetamol

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

Official Title
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A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.

Conditions
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Fever, Headache Disorders, Pain

Intervention / Treatment
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* Drug: Paracetamol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Paracetamol Tablet<br>Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water. | Drug: Paracetamol<br>* 500 mg immediate release paracetamol formulations<br>|
| Active Comparator: Standard Paracetamol Tablet (500 mg)<br>Standard paracetamol tablet (500 mg) administered with 240 mL of water. | Drug: Paracetamol<br>* 500 mg immediate release paracetamol formulations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0-inf) | Area under the plasma concentration time curve from zero and extrapolated to infinite time. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. | 
| Cmax | Maximum plasma concentration of paracetamol. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. | 
| AUC (0-t) | Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Time taken to reach maximum plasma concentration of paracetamol. | Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose. |