Journal of Bioequivalence & Bioavailability

Integrated Product Development, Cipla Limited, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, India

Publications

• Research Article   
  Assessment of Bioequivalence between the Higher Strengths of Pirfenidone 400 mg and 600 mg with Equivalent Doses of Pirfenidone 200 mg
  Author(s): Hemant Joshi*, Mukesh Kumar, Jaideep Gogtay, Meena Lopez, Milind Gole and Richa Sharma
  
  Background: The standard of care for idiopathic pulmonary fibrosis is pirfenidone 200 mg tablets thrice daily (t.i.d, 600 mg/day) which is titrated to achieve the desired maintenance dose i.e 1800-2400 mg/day (600 mg-800 mg, t.i.d). However, this is associated with a high pill burden and can impact patient compliance. Therefore, two higher strengths (400 mg and 600 mg) of pirfenidone tablets have been developed which offer greater flexibility to facilitate tailored dosing and likely to improve patient compliance. Methods: Two studies were conducted using an open-label, randomized, single-dose, two-treatment, two-period, twosequence, two-way crossover design in fed conditions with a washout period of 5-6 days between administration. In the first study, a single dose of 400 mg pirfenidone tablet was compared with 2 × 200 .. View more»
  

  DOI: 10.35248/0975-0851.22.14.473

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