Trial reportAdvances in therapy2017
A Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers.
Trial report in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02525484 (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), which is not on this map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
10 citing papers in PubMed.
- Efficacy and tolerability of generic pirfenidone after switch from EsbrietInternal and emergency medicine · 2026Observational
- Integrative Perspectives on Pirfenidone: Mechanistic Insights, Pharmacodynamics, and Emerging Therapeutic Strategies for Fibrotic Disorders.AAPS PharmSciTech · 2026Review
- Citrus pectin-coated inhalable PLGA nanoparticles for treatment of pulmonary fibrosis.Journal of materials chemistry. B · 2025Article
- Applying the estimand framework to clinical pharmacology trials with a case study in bioequivalence.British journal of clinical pharmacology · 2025Review
- Post-marketing safety concerns with pirfenidone and nintedanib: an analysis of individual case safety reports from the FDA adverse event reporting system database and the Japanese adverse drug event report databases.Frontiers in pharmacology · 2025Article
- Otilonium bromide ameliorates pulmonary fibrosis in mice through activating phosphatase PPM1A.Acta pharmacologica Sinica · 2025Article
- Targeting the Wnt signaling pathway through R-spondin 3 identifies an anti-fibrosis treatment strategy for multiple organs.PloS one · 2020Article
- Real-World Practice Patterns for Prevention and Management of Potential Adverse Events with Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.Pulmonary therapy · 2018Article
- Casein Kinase 1δ/ε Inhibitor, PF670462 Attenuates the Fibrogenic Effects of Transforming Growth Factor-β in Pulmonary Fibrosis.Frontiers in pharmacology · 2018Article
- Pirfenidone tablets in idiopathic pulmonary fibrosis: a profile of their use.Drugs & therapy perspectives : for rational drug selection and use · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states.
methodsA Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an 801-mg single dose of pirfenidone as three 267-mg capsules or one 801-mg tablet under fasted and fed conditions. Pirfenidone plasma C
resultsForty-four subjects were randomized to treatment. The 801-mg tablet in the fasted state met bioequivalence criteria [90% confidence intervals (CI) 80.00-125.00%] for the GLSM ratios of natural log-transformed C
conclusionsThe pirfenidone 801-mg tablet met bioequivalence criteria when compared with three 267-mg capsules in the fasted state. The tablet C
fundingThis work was supported by F. Hoffmann-La Roche Ltd.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.