Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07478133
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:
NCT07478133
Study Brief:
Protocol Section:
NCT07478133