Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 11:32 AM
Study NCT ID:
NCT07478133
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans
Sponsor:
Shandong New Time Pharmaceutical Co., LTD
Organization:
Study Overview
Official Title:
Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans
Status:
COMPLETED
Status Verified Date:
2026-03
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:
The test formulation of Nalfurafine Hydrochloride Orally Disintegrating Tablets (2.5 μg) is bioequivalent to the reference formulation (Remitch®) in healthy Chinese subjects under fed conditions.
Detailed Description:
This is a single-center, randomized, open-label, single-dose, two-formulation, two-sequence crossover study designed to evaluate the bioequivalence and safety of a generic formulation versus the reference formulation of Nalfurafine Hydrochloride Orally Disintegrating Tablets (2.5 μg) in healthy Chinese male and female subjects under fed conditions. A planned total of 72 eligible subjects will be enrolled. Venous blood samples are collected for the determination of plasma concentrations of nalfurafine. In each study period, samples are taken at pre-dose (0#h) and at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5,4, 4.5, 5, 6, 8, 10, 12, 24, and 36 #h post-dose.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: