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Status unknownNCT04420234Updated Sep 9, 2020

A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets

A Phase 1 interventional study of narfurine hydrochloride orally disintegrating tablets in Improvement of Pruritus in Hemodialysis Patients, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-09.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study summary

Main objective: To evaluate the pharmacokinetics of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.

Secondary objective: To evaluate the safety profile of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.

02

Conditions studied

  • Improvement of Pruritus in Hemodialysis Patients

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Keywords

  • narfurine hydrochloride orally disintegrating tablets
03

In context

Pruritus

354 studies on the registry are indexed under Pruritus; 74 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 294 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 18 years old \<= age \<= 40 years old, male or female;
  2. Weight: male >= 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg / m2 (including 19 and 26);
  3. Important indicators including physical examination, vital signs examination, electrocardiogram examination, laboratory examination, and chest X-ray examination are normal or within the acceptable range of the sponsors or researchers;
  4. During the trial and within 3 months after the last medication, there is no parenting plan and reliable contraceptive measures could be taken;
  5. Fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign a written informed consent form, and can complete the entire trial process according to the trial requirements.

Exclusion criteria

Exclusion Criteria:

  1. Those who are known to have a history of allergies, allergic diseases or allergies to the test preparation and any of its components or related preparations;
  2. Those who have a clear medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders or serious infections and serious injuries, or other diseases that are not suitable for participating in clinical trials (such as history of mental illness, etc.)
  3. Those who have donated blood or lost blood >= 400mL within 3 months before enrollment;
  4. Those who have taken any drugs (including prescription drugs and over-the-counter drugs), vitamins, and Chinese herbal medicines within 2 weeks before screening;
  5. Those who have participated in clinical trials of other drugs or medical devices within 3 months before being selected;
  6. Those who is or was a drug addict or positive in drug abuse screening test;
  7. Those who is or was an alcoholic (drinking more than 14 standard units per week. 1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or positive in urine alcohol test.
  8. Smokers or those with an average daily smoking volume of more than 5 cigarettes within 3 months before screening, and those with a positive nicotine test;
  9. Those who is positive in Hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody and HIV antibody;
  10. Female subjects who are in the lactation period or is positive in the pregnancy test during the screening period or clinical trial;
  11. Those who have used any drugs that is CYP3A4 inhibitor or inducer within 4 weeks before signing the informed consent form, see Appendix 3 for details;
  12. People with long-term insomnia and those with the habit of taking sleeping pills;
  13. People with habitual constipation;
  14. Those who is diagnosed abnormal or with clinical significance in physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, etc.,
  15. Those who have undergone surgery that can affect the absorption, distribution, metabolism, excretion of drugs, or have any gastrointestinal diseases that may affect the absorption of drugs, or those who are determined by the investigator to be unsuitable for enrollment;
  16. Those who consume excessive amounts of tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250mL) every day within 30 days before screening
  17. Those who took grapefruit or grapefruit juice and drinks or foods containing St. John's wort (hypericum perforatum), ginseng, ginkgo, valerian, and echinacea within 48 hours before administration;
  18. Those who is diagnosed abnormal or have clinical significance by researchers in the chest X-ray examination;
  19. Those who develop new diseases during the pre-study screening stage or before study medication;
  20. Those who cannot tolerate venipuncture blood collection;
  21. Those who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Pharmacokinetics study of single and multiple administration

    During the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile.

    Drug: narfurine hydrochloride orally disintegrating tablets

Interventions

  • Drugnarfurine hydrochloride orally disintegrating tablets

    Subjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning).

06

What researchers measure

Primary outcomes

  1. AUC AUC

    Area Under the Plasma Concentration-time Curve

    Time frame: Day1 to Day13

  2. Cmax

    Maximum Observed Plasma Concentration

    Time frame: Day1 to Day13

  3. Tmax

    Time to Reach the Maximum Plasma Concentration

    Time frame: Day1 to Day13

  4. t1/2

    Elimination half-life

    Time frame: Day1 to Day13

  5. Kel

    Elimination rate constant

    Time frame: Day1 to Day13

  6. CL/F CL/F

    Apparent clearance

    Time frame: Day1 to Day13

  7. Vd/F

    Apparent distribution volume based on terminal elimination phase

    Time frame: Day1 to Day13

  8. MRT

    Mean residence time

    Time frame: Day1 to Day13

  9. Css_max

    Steady state peak concentration

    Time frame: Day1 to Day13

  10. Css_min

    Steady state Valley concentration

    Time frame: Day1 to Day13

  11. Css_av

    Steady state average concentration

    Time frame: Day1 to Day13

  12. DF

    Volatility index

    Time frame: Day1 to Day13

  13. Safety and tolerance indicators

    AE and SAE

    Time frame: Day1 to Day13

07

Study locations

1 site
  • The First Affiliated Hospital,ZheJiang Univercity
    Hanzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04420234
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
Jun 9, 2020
Primary completion
Jul 28, 2020
Completion
Dec 2020 (estimated)
Last update
Sep 9, 2020

Study contacts

jian liu, master
principal investigator · The First Affiliated Hospital,ZheJiang Univercity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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