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NCT02525484 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT02525484: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02525484 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02525484, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after administration of tablet and capsule dosage forms under both fed and fasted conditions.
Interventions
- DRUG Pirfenidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT02525484 record still lists
NCT02525484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which Pirfenidone is the first listed.
NCT02525484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02525484 about?
NCT02525484 is a clinical study titled "A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants". This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after administration of tablet and capsule dosage forms under both fed and fasted conditions.
What is the current status of trial NCT02525484?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2015-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02525484?
The interventions under investigation include: Pirfenidone (DRUG).
Who is sponsoring clinical trial NCT02525484?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02525484's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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