Food-Effect Pharmacokinetic Study of PL2200

PLx Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PL2200 fed; Drug: PL2200 fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT01244100

PL-ASA-003

Details and patient eligibility

About

This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

20 participants in 1 patient group

PL2200

Experimental group

Treatment:

Drug: PL2200 fasted

Drug: PL2200 fed