Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers

Summary

This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule x 3) given in the fed state, to healthy volunteers.

Timeline

Start

2022-08-08

Primary completion

2022-09-25

Completion

2022-09-25

Drugs

Indications