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A Phase I, Open-Label, Randomized, Four-Treatment Period, Four-Sequence, Single-Dose, Crossover, Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers

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Trial Profile

A Phase I, Open-Label, Randomized, Four-Treatment Period, Four-Sequence, Single-Dose, Crossover, Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Pirfenidone (Primary) ; Pirfenidone (Primary)
  • Indications Acute lung injury; Idiopathic pulmonary fibrosis
  • Focus Pharmacokinetics
  • Sponsors Roche

Most Recent Events

  • 14 Aug 2017 Primary endpoint (AUC from Time Zero to Infinity (AUC[0-inf]) of Pirfenidone, in fed and fasted state, 1 801-mg tablet vs 3 267-mg capsules) has been met as per the results published in the Advances in Therapy
  • 14 Aug 2017 Primary endpoint (Area Under the Plasma Concentration Versus Time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Pirfenidone, in fed and fasted state, 1 801-mg tablet vs 3 267-mg capsules) has been met as per the results published in the Advances in Therapy
  • 14 Aug 2017 Primary endpoint (Peak Plasma Concentration (Cmax) of Pirfenidone, in fed state, 1 801-mg tablet vs 3 267-mg capsules) has not been met as per the results published in the Advances in Therapy

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