PruritusNCT07478133
Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans
A study testing Nalfurafine Hydrochloride Orally Disintegrating Tablets and Remitch® in people with Pruritus, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- Nalfurafine Hydrochloride Orally Disintegrating Tablets and Remitch®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2023to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Participation in another clinical trial and use of investigational drugs or devices within 3 months prior to screening, or planned participation in other clinical trials during this study, or participation in clinical trials not conducted in person;
- Pregnant or breastfeeding women, or male subjects (or their partners) or female subjects with pregnancy plans within 2 weeks prior to screening to 3 months after the study, or unwillingness to adopt a medically recognized non-drug contraceptive method (such as intrauterine devices or condoms) during the study;
- Difficulty in blood collection, a history of needle phobia or blood phobia, or inability to tolerate venous puncture;
- Abnormalities in physical examination, blood routine, blood biochemistry, urine routine, 12-lead electrocardiogram, coagulation function, infectious disease screening, or pregnancy test (applicable to female subjects) that are clinically significant;
- Abnormal vital signs that remain abnormal after re-examination;
- Subjects deemed unsuitable for enrollment by the investigator or those who withdraw for personal reasons.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Nalfurafine Hydrochloride Orally Disintegrating Tablets, Remitch®
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalfurafine Hydrochloride Orally Disintegrating TabletsDrug
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).
Remitch®Drug
Reference Product. Manufacturer: Toray Co. Ltd. Form/Strength: 2.5 μg tablet Administration: Single oral dose of 2.5 μg (1 tablet).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nalfurafine Hydrochloride Orally Disintegrating Tablets; Drug: Remitch® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 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
Measured: 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
Measured: 36 hours post-dose in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start24 May 2023
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478133
- Sponsor's protocol ID
- NTP-NFLF-T-BEO1
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans
- ClinicalTrials.gov ID
- NCT07478133
- Acronym / sponsor ID
- NTP-NFLF-T-BEO1
- Conditions
- Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Drug: Nalfurafine Hydrochloride Orally Disintegrating Tablets, Drug: Remitch®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. |
| Fed | Experimental | Drug: Nalfurafine Hydrochloride Orally Disintegrating Tablets, Drug: Remitch®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalfurafine Hydrochloride Orally Disintegrating TabletsTest 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 | Fasting, Fed |
| Remitch®Reference Product. Manufacturer: Toray Co. Ltd. Form/Strength: 2.5 μg tablet Administration: Single oral dose of 2.5 μg (1 tablet). | Drug | Fasting, Fed |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 36 hours post-dose in each period
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
Time frame: 36 hours post-dose in each period
plasma concentration-time curve from zero to the time of the last measurable time point t
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 36 hours post-dose in each period
area under the plasma concentration-time curve from zero to infinity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nalfurafine Hydrochloride Orally Disintegrating Tablets and Remitch® in people with Pruritus, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 36 hours post-dose in each period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.