NCT07478133

Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pruritus

Interventions

Type	Name	Description
DRUG	Nalfurafine Hydrochloride Orally Disintegrating Tablets	Test Product. Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. Dosage Form/Strength: 2.5 μg tablet Administration: Single oral dose of 2.5 μg (1 tablet).
DRUG	Remitch®	Reference Product. Manufacturer: Toray Co. Ltd. Form/Strength: 2.5 μg tablet Administration: Single oral dose of 2.5 μg (1 tablet).

Timeline

• Start date: 2023-05-24
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: China