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drugset / Trial / NCT01244100

Food-Effect Pharmacokinetic Study of PL2200

NCT01244100 ↗

Phase 1 Completed 20 enrolled PLx Pharma

RandomizedCrossoverSingle-blind

Summary

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

Timeline

Start: 2010-10
Primary completion: 2010-12
Completion: —

Outcome

Met primary endpoint

paper AUC0-t and AUC0-∞ were 88.7% and 88.8% respectively, with 90% confidence intervals between 80 and 125% PMID 32080811 ↗

Publications

Angiolillo DJ, Bhatt DL, Lanza F, Deliargyris EN, Prats J, Fan W, Marathi U. Bioavailability of aspirin in fasted and fed states of a novel pharmaceutical lipid aspirin complex formulation. J Thromb Thrombolysis. 2020 Apr;49(3):337-343. doi: 10.1007/s11239-020-02051-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	650 mg	—

Indications

No indication recorded.