Last reviewed · How we verify
NCT06588517
Comparative Pharmacokinetic(PK) Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions
Phase 1 trial testing Pirfenidone Modified-Release Tablets in Idiopathic Pulmonary Fibrosis in 12 participants. Completed in 27 April 2024.
19 April 2024
Quick facts
| Lead sponsor | Overseas Pharmaceuticals, Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 12 |
| Start date | 8 April 2024 |
| Primary completion | 19 April 2024 |
| Estimated completion | 27 April 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Pirfenidone Modified-Release Tablets — full drug profile →
- Pirfenidone Tablets — full drug profile →
Conditions studied
- Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
Sponsor
Overseas Pharmaceuticals, Ltd. — full company profile →
Who can join
18 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Randomized, Open-Label, Two-Period, Double-Crossover Comparative Study on the Pharmacokinetics of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Chinese Subjects under Fed Conditions Primary objective: To evaluate the bioequivalence of test product and reference product by comparing their plasma concentrations and main PK parameters by oral administration in healthy Chinese subjects under fed conditions using Pirfenidone Modified-Release Tablets (strength: 600 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product and Pirfenidone Tablets (trade name: Pirespa®, strength: 200 mg/tablet) produced by Shionogi \& Co., Ltd. as the reference product. Secondary objective: To evaluate the safety of Pirfenidone Modified-Release Tablets (test product) and Pirfenidone Tablets (reference product) after oral administration in healthy Chinese subjects under fed conditions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06588517
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pirfenidone Modified-Release Tablets
Trials testing the same drug.
- NCT06569381 — Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Cond · Phase 1 · completed
- NCT06589921 — Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Un · Phase 1 · completed
Other recruiting trials for Idiopathic Pulmonary Fibrosis
Currently open trials in the same condition.
- NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF · Phase 1 · recruiting
- NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
- NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc · Phase 1 · recruiting
- NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · recruiting
- NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting
Other Overseas Pharmaceuticals, Ltd. trials
Trials by the same sponsor.
- NCT06569381 — Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Cond · Phase 1 · completed
- NCT06890715 — Comparative Pharmacokinetic Study of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Healthy Subjects · Phase 1 · completed
- NCT06589921 — Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Un · Phase 1 · completed
- NCT05729555 — Comparative Pharmacokinetic (PK) Study of Ibuprofen and Diphenhydramine Hydrochloride MR Tablets in Healthy Adults Under · Phase 1 · unknown
- NCT05788159 — An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmac · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06588517 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Overseas Pharmaceuticals, Ltd.
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06588517.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing