Food-Effect Pharmacokinetic Study of PL2200

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PL2200 fasted; Drug: PL2200 fed

• Registration Number: NCT01244100
• Lead Sponsor: PLx Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-19
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Last Update Submitted: 2010-12-10
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PL2200	PL2200 fasted	-
PL2200	PL2200 fed	-

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Houston Institute for Clinical Research; 🇺🇸 Houston, Texas, United States