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NCT05428150 · ClinicalTrials.gov registry record · Phase 1
Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers
A Phase 1 study of Idiopathic Pulmonary Fibrosis, sponsored by Excalibur Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05428150 is a Phase 1 study of Idiopathic Pulmonary Fibrosis that has completed, run by Excalibur Pharmaceuticals. The registered enrollment target is 32 participants, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05428150, a Phase 1 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Excalibur Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule x 3) given in the fed state, to healthy volunteers.
Conditions Studied
Interventions
- DRUG Esbriet 267 MG Oral Capsule
- DRUG EXCL-100, 600 MG Oral Tablet
Study Locations (1)
Ohio
- Medpace Clinical Pharmacology Unit - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2022-09-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05428150
The ClinicalTrials.gov registry entry for NCT05428150 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (96% lower). The listed sponsor is Excalibur Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Esbriet 267 MG Oral Capsule is the first listed.
NCT05428150 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05428150 about?
NCT05428150 is a clinical study titled "Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers". This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule...
What is the current status of trial NCT05428150?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-08-08. Estimated completion is 2022-09-25.
What conditions does trial NCT05428150 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT05428150?
The interventions under investigation include: Esbriet 267 MG Oral Capsule (DRUG), EXCL-100, 600 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05428150?
This trial is sponsored by Excalibur Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05428150 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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