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

NCT07478133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Shandong New Time Pharmaceutical Co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2023-07-14
Completion
2023-07-14

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07478133 on ClinicalTrials.gov