Healthy Subjects
Conditions
Keywords
pharmacokinetic, paracetamol, Healthy volunteer, steady state
Brief summary
A repeat dose pharmacokinetic study investigating two paracetamol formulations
Interventions
experimental
Marketed paracetamol
DRUGHigher dose marketed paracetamol
Higher dose marketed paracetamol
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 health 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 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 (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence as measured by Area Under the Curve (AUC) | last 24 hours of dosing |
Secondary
| Measure | Time frame |
|---|---|
| Time duration at or above minimal therapeutic plasma paracetamol concentration | last 24 hours of dosing |
| To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel) | last 24 hours of dosing |
| Adverse events | Baseline to 72 hours post dosing |
Countries
United States
Outcome results
None listed