Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT01540721
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental paracetamol formulation Experimental paracetamol formulation Experimental formulation Marketed paracetamol Marketed paracetamol Marketed formulation
- Primary Outcome Measures
Name Time Method Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state baseline to 12 hours Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax baseline to 12 hours
- Secondary Outcome Measures
Name Time Method To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC) baseline to 12 hours
Trial Locations
- Locations (1)
MDS Pharma Services NEBRASKA
🇺🇸Lincoln, Nebraska, United States