A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.
Overview
- Phase
- Phase 1
- Intervention
- Paracetamol
- Conditions
- Fever
- Sponsor
- GlaxoSmithKline
- Enrollment
- 30
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.
Investigators
Eligibility Criteria
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
Arms & Interventions
Experimental Paracetamol Tablet
Experimental paracetamol tablet (500 milligrams \[mg\]) administered with 240 milliliters (mL) of water.
Intervention: Paracetamol
Standard Paracetamol Tablet (500 mg)
Standard paracetamol tablet (500 mg) administered with 240 mL of water.
Intervention: Paracetamol
Outcomes
Primary Outcomes
Cmax
Time Frame: 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.
Maximum plasma concentration of paracetamol.
AUC (0-t)
Time Frame: 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.
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
AUC (0-inf)
Time Frame: 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.
Area under the plasma concentration time curve from zero and extrapolated to infinite time.
Secondary Outcomes
- Tmax(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.)