Back to resultsPharmacokinetic Study to Compare Two Formulations of Paracetamol
Primary Purpose
Fever, Headache Disorders, Pain
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Fever
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Paracetamol Tablet
Standard Paracetamol Tablet (500 mg)
Arm Description
Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water.
Standard paracetamol tablet (500 mg) administered with 240 mL of water.
Outcomes
Primary Outcome Measures
AUC (0-inf)
Area under the plasma concentration time curve from zero and extrapolated to infinite time.
Cmax
Maximum plasma concentration of paracetamol.
AUC (0-t)
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
Secondary Outcome Measures
Tmax
Time taken to reach maximum plasma concentration of paracetamol.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01767428
Brief Title
Pharmacokinetic Study to Compare Two Formulations of Paracetamol
Official Title
A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Headache Disorders, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Paracetamol Tablet
Arm Type
Experimental
Arm Description
Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water.
Arm Title
Standard Paracetamol Tablet (500 mg)
Arm Type
Active Comparator
Arm Description
Standard paracetamol tablet (500 mg) administered with 240 mL of water.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
500 mg immediate release paracetamol formulations
Primary Outcome Measure Information:
Title
AUC (0-inf)
Description
Area under the plasma concentration time curve from zero and extrapolated to infinite time.
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.
Title
Cmax
Description
Maximum plasma concentration of paracetamol.
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.
Title
AUC (0-t)
Description
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
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.
Secondary Outcome Measure Information:
Title
Tmax
Description
Time taken to reach maximum plasma concentration of paracetamol.
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study to Compare Two Formulations of Paracetamol
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