NCT01540721
Completed
Phase 1
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations
ConditionsHealthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Experimental paracetamol formulation
- Conditions
- Healthy Subjects
- Sponsor
- GlaxoSmithKline
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
Exclusion Criteria
- •Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.
Arms & Interventions
Experimental paracetamol formulation
Experimental formulation
Intervention: Experimental paracetamol formulation
Marketed paracetamol
Marketed formulation
Intervention: Marketed paracetamol
Outcomes
Primary Outcomes
Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
Time Frame: baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
Time Frame: baseline to 12 hours
Secondary Outcomes
- To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)(baseline to 12 hours)
Study Sites (1)
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