Healthy Subjects
Conditions
Keywords
paracetamol, pharmacokinetic
Brief summary
A single dose pharmacokinetic study investigating two paracetamol formulations
Interventions
Marketed formulation
Experimental formulation
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare bioavailability as measured by Area under the Curve in both fed and fasted states | 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 | Visit 1 through Visit 3 (Day 13) |
Secondary
| Measure | Time frame |
|---|---|
| To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax) | Visit 1 through Visit 3 (Day 13) |
Countries
United States
Outcome results
None listed