Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-01 @ 8:16 AM
Study NCT ID:
NCT05428150
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers
Sponsor:
Excalibur Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Randomized, Crossover, Multi-Dose, Steady State, Comparative Pharmacokinetics and Relative Bioavailability Study of EXCL-100 Pirfenidone-Sustained Release Tablet (EXCL-100), and Esbriet® in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
After signing the Institutional Review Board (IRB) approved Informed Consent Form (ICF), subjects will undergo a screening evaluation up to 28 days prior to dosing on Day 1 of Period 1. Subjects who satisfy the screening evaluation and who meet the inclusion and exclusion criteria will be enrolled in the study. Subjects will receive multiple doses of study drug according to their assigned sequence of treatment in Period 1. After completion of study procedures, a washout period will be completed prior to crossover to Period 2 to receive the second treatment in their sequence. Subjects will receive Regimens A (Esbriet® 801 mg three times daily with meals for 3 days) and B (EXCL-100, 1200 mg twice daily with meals) according to the randomization schedule. Pharmacokinetic (PK) blood samples will be taken on multiple days during the study periods.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: