Clinical Trial

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

Name: Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans — clinical trial record (NCT07478133)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Completed

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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.

Trial Details

NCT Number	NCT07478133
Lead Sponsor	Shandong New Time Pharmaceutical Co., LTD
Conditions	Pruritus
Enrollment	72 participants
Start Date	2023-05-24
Primary Completion	2023-07-14 (estimated)
Study Completion	2023-07-14 (estimated)
Updated on ClinicalTrials.gov	2026-03-17