NCT01540734
Completed
Phase 1
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations
ConditionsHealthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Marketed paracetamol
- Conditions
- Healthy Subjects
- Sponsor
- GlaxoSmithKline
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- To compare bioavailability as measured by Area under the Curve in both fed and fasted states
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
A single dose pharmacokinetic study investigating two paracetamol formulations
Investigators
Eligibility Criteria
Inclusion Criteria
- •Good general heatlh with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
Exclusion Criteria
- •Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the remainder of the study.
- •Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Current (within 14 days of screening) or regular use of any prescription, over the counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.
Arms & Interventions
Marketed paracetamol
marketed formulation
Intervention: Marketed paracetamol
Experimental paracetamol formulation
Experimental formulation
Intervention: Experimental paracetamol formulation
Outcomes
Primary Outcomes
To compare bioavailability as measured by Area under the Curve in both fed and fasted states
Time Frame: Visit 1 through Visit 3 (Day 13)
To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax
Time Frame: Visit 1 through Visit 3 (Day 13)
Secondary Outcomes
- To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)(Visit 1 through Visit 3 (Day 13))
Study Sites (1)
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