A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets
Primary Purpose
Improvement of Pruritus in Hemodialysis Patients
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
narfurine hydrochloride orally disintegrating tablets
Sponsored by
About this trial
This is an interventional treatment trial for Improvement of Pruritus in Hemodialysis Patients focused on measuring narfurine hydrochloride orally disintegrating tablets
Eligibility Criteria
Inclusion Criteria:
- 18 years old <= age <= 40 years old, male or female;
- Weight: male >= 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg / m2 (including 19 and 26);
- 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;
- During the trial and within 3 months after the last medication, there is no parenting plan and reliable contraceptive measures could be taken;
- 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:
- 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;
- 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.)
- Those who have donated blood or lost blood >= 400mL within 3 months before enrollment;
- Those who have taken any drugs (including prescription drugs and over-the-counter drugs), vitamins, and Chinese herbal medicines within 2 weeks before screening;
- Those who have participated in clinical trials of other drugs or medical devices within 3 months before being selected;
- Those who is or was a drug addict or positive in drug abuse screening test;
- 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.
- 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;
- Those who is positive in Hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody and HIV antibody;
- Female subjects who are in the lactation period or is positive in the pregnancy test during the screening period or clinical trial;
- 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;
- People with long-term insomnia and those with the habit of taking sleeping pills;
- People with habitual constipation;
- Those who is diagnosed abnormal or with clinical significance in physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, etc.,
- 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;
- 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
- 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;
- Those who is diagnosed abnormal or have clinical significance by researchers in the chest X-ray examination;
- Those who develop new diseases during the pre-study screening stage or before study medication;
- Those who cannot tolerate venipuncture blood collection;
- Those who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
Sites / Locations
- The First Affiliated Hospital,ZheJiang Univercity
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pharmacokinetics study of single and multiple administration
Arm Description
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.
Outcomes
Primary Outcome Measures
AUC AUC
Area Under the Plasma Concentration-time Curve
Cmax
Maximum Observed Plasma Concentration
Tmax
Time to Reach the Maximum Plasma Concentration
t1/2
Elimination half-life
Kel
Elimination rate constant
CL/F CL/F
Apparent clearance
Vd/F
Apparent distribution volume based on terminal elimination phase
MRT
Mean residence time
Css_max
Steady state peak concentration
Css_min
Steady state Valley concentration
Css_av
Steady state average concentration
DF
Volatility index
Safety and tolerance indicators
AE and SAE
Secondary Outcome Measures
Full Information
NCT ID
NCT04420234
First Posted
June 4, 2020
Last Updated
September 7, 2020
Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04420234
Brief Title
A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets
Official Title
A Single-center Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Single and Multiple Oral Administration of Narfurine Hydrochloride Orally Disintegrating Tablets in Chinese Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improvement of Pruritus in Hemodialysis Patients
Keywords
narfurine hydrochloride orally disintegrating tablets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacokinetics study of single and multiple administration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
narfurine hydrochloride orally disintegrating tablets
Intervention Description
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).
Primary Outcome Measure Information:
Title
AUC AUC
Description
Area Under the Plasma Concentration-time Curve
Time Frame
Day1 to Day13
Title
Cmax
Description
Maximum Observed Plasma Concentration
Time Frame
Day1 to Day13
Title
Tmax
Description
Time to Reach the Maximum Plasma Concentration
Time Frame
Day1 to Day13
Title
t1/2
Description
Elimination half-life
Time Frame
Day1 to Day13
Title
Kel
Description
Elimination rate constant
Time Frame
Day1 to Day13
Title
CL/F CL/F
Description
Apparent clearance
Time Frame
Day1 to Day13
Title
Vd/F
Description
Apparent distribution volume based on terminal elimination phase
Time Frame
Day1 to Day13
Title
MRT
Description
Mean residence time
Time Frame
Day1 to Day13
Title
Css_max
Description
Steady state peak concentration
Time Frame
Day1 to Day13
Title
Css_min
Description
Steady state Valley concentration
Time Frame
Day1 to Day13
Title
Css_av
Description
Steady state average concentration
Time Frame
Day1 to Day13
Title
DF
Description
Volatility index
Time Frame
Day1 to Day13
Title
Safety and tolerance indicators
Description
AE and SAE
Time Frame
Day1 to Day13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years old <= age <= 40 years old, male or female;
Weight: male >= 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg / m2 (including 19 and 26);
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;
During the trial and within 3 months after the last medication, there is no parenting plan and reliable contraceptive measures could be taken;
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:
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;
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.)
Those who have donated blood or lost blood >= 400mL within 3 months before enrollment;
Those who have taken any drugs (including prescription drugs and over-the-counter drugs), vitamins, and Chinese herbal medicines within 2 weeks before screening;
Those who have participated in clinical trials of other drugs or medical devices within 3 months before being selected;
Those who is or was a drug addict or positive in drug abuse screening test;
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.
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;
Those who is positive in Hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody and HIV antibody;
Female subjects who are in the lactation period or is positive in the pregnancy test during the screening period or clinical trial;
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;
People with long-term insomnia and those with the habit of taking sleeping pills;
People with habitual constipation;
Those who is diagnosed abnormal or with clinical significance in physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, etc.,
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;
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
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;
Those who is diagnosed abnormal or have clinical significance by researchers in the chest X-ray examination;
Those who develop new diseases during the pre-study screening stage or before study medication;
Those who cannot tolerate venipuncture blood collection;
Those who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jian liu, master
Organizational Affiliation
The First Affiliated Hospital,ZheJiang Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital,ZheJiang Univercity
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets
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