Healthy
Conditions
Keywords
Food-effects PK study in healthy subjects.
Brief summary
This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.
Interventions
DRUGPL2200 fasted
Fasted state
DRUGPL2200 fed
Fed state
Sponsors
PLx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy normal male and female volunteers between 21 and 65 years of age.
Exclusion criteria
* Abnormal findings on physical examination or clinical laboratories, or significant medical history. * Subject with hypersensitivity or contraindications to aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drug (NSAID).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-inf of the primary metabolite, salicylic acid, in the fed state versus the fasted state. | 24 hours |
| Effect of food by ratio of least-squares means (LSM) of the PK parameter of Cmax of the primary metabolite, salicylic acid, in the fed state versus the fasted state. | 24 hours |
| Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state. | 24 hours |
Countries
United States
Outcome results
None listed