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

NCT07478133 | Completed

• 1 other identifier: NTP-NFLF-T-BEO1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  36 hours post-dose in each period

• Area under the plasma concentration versus time curve (AUC) 0-t

  plasma concentration-time curve from zero to the time of the last measurable time point t

  36 hours post-dose in each period

• Area under the plasma concentration versus time curve (AUC)0-∞

  area under the plasma concentration-time curve from zero to infinity

  36 hours post-dose in each period

Other Outcomes (2)

• maximum plasma concentration (tmax)

  36 hours post-dose in each period

• Incidence of Treatment-Emergent Adverse Events

  10 Days

Study Arms (2)

Fasting

EXPERIMENTAL

Healthy male and female subjects will be randomized to receive a single oral dose of the Test and Reference formulations under fasting conditions, according to a two-period, two-sequence crossover design with a 7-day washout period between periods.

Drug: Nalfurafine Hydrochloride Orally Disintegrating Tablets; Drug: Remitch®

Fed

EXPERIMENTAL

Healthy male and female subjects will be randomized to receive a single oral dose of the Test and Reference formulations under fed conditions (30 minutes after a high-fat, high-calorie meal), according to a two-period, two-sequence crossover design with a 7-day washout period between periods. The two arms (fasting and fed) are conducted in parallel without crossover between arms.

Drug: Nalfurafine Hydrochloride Orally Disintegrating Tablets; Drug: Remitch®

Interventions

Nalfurafine Hydrochloride Orally Disintegrating Tablets DRUG

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).

Fasting; Fed

Remitch® DRUG

Reference Product. Manufacturer: Toray Co. Ltd. Form/Strength: 2.5 μg tablet Administration: Single oral dose of 2.5 μg (1 tablet).

Fasting; Fed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate and sign the informed consent form, with the informed consent process complying with GCP requirements;
• Healthy male or female;
• Aged 18 years or older;
• Female body weight ≥45.0 kg, male body weight ≥50.0 kg, with body mass index (BMI) = weight (kg) / height² (m²), and BMI within the range of 19.0-26.0 kg/m², inclusive.

You may not qualify if:

• A history or current presence of abnormalities in the motor system, nervous system, mental system, endocrine system, blood circulation system, respiratory system, digestive system, urinary system, or reproductive system, which is deemed clinically significant by the investigator;
• Undergone surgery within 3 months prior to screening or during the screening period, or undergone surgery that affects drug absorption, distribution, metabolism, or excretion, or planned surgery during the study period;
• A history of habitual constipation;
• Chronic insomnia or a habit of taking sleeping pills;
• Blood donation or significant blood loss (≥400 mL) within 3 months prior to screening or during the screening period (excluding physiological blood loss in women);
• A history of drug abuse within the past 5 years or a positive result in drug screening;
• A specific allergy history (asthma, urticaria, eczema, etc.), or allergies to drugs, environments, foods, or known allergy to the components or analogs of this drug;
• Excessive consumption of tea, coffee, or caffeinated beverages within 3 months prior to screening (more than 8 cups per day, 1 cup = 250 mL), or intake of any food or beverage containing alcohol, caffeine, or xanthine-rich substances (such as coffee, strong tea, chocolate, cola, grapefruit, etc.) within 48 hours before taking the investigational drug;
• Alcohol abuse within 3 months prior to screening (consuming more than 14 units of alcohol per week: 1 unit ≈ 285 mL of beer, 25 mL of spirits, or 100 mL of wine), unwillingness to abstain from alcohol during the study, or an alcohol breath test result \> 0 mg/100 mL;
• Smoking ≥5 cigarettes per day within 3 months prior to screening or unwillingness to quit smoking during the study;
• Inability to adhere to a uniform diet or difficulty swallowing;
• Intolerance to standard meals or lactose intolerance (e.g., diarrhea after consuming milk);
• Use of any prescription drugs, over-the-counter medications, herbal medicines, or health supplements within 14 days prior to screening;
• Use of any drugs that inhibit or induce liver metabolism of drugs within 28 days prior to screening;
• Vaccination within 28 days prior to screening or planned vaccination during the study period;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, 214000, China

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: May 24, 2023
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)