Food-Effect Pharmacokinetic Study of PL2200

Phase 1CompletedNCT01244100

PLx Pharma20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

PL2200 fastedDRUG

Fasted state

PL2200 fedDRUG

Fed state

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Houston Institute for Clinical Research

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

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.

Time frame: 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.

Time frame: 24 hours

Data from ClinicalTrials.gov

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