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The Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects

Primary Purpose

PHN - Post-Herpetic Neuritis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HSK16149,probenecid, cimetidine
Sponsored by
Haisco Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PHN - Post-Herpetic Neuritis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 50 years (inclusive), male and female; Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-28 kg/m2 (inclusive); Physical examination, vital sign measurements results were deemed appropriate by the investigator; Not in use of any drug within 2 weeks prior to screening; 7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration. Exclusion Criteria: Have an allergic history to the main ingredients and/or any auxiliary materials in the research preparation, allergic diseases or allergies, or allergic history to pregabalin or gabapentin, or allergic history to pregabalin or gabapentin or sulfonamides; Have special requirements for diet and cannot follow the unified diet; The abnormal results of 12-lead electrocardiogram (ECG), chest X-ray (positive position) and routine laboratory tests (blood routine, blood biochemistry, urine routine and coagulation function) during the screening period have clinical significance and are judged by the researchers to be unsuitable to participate in this experiment; In the screening period, male QTcF>450 milliseconds (msec) and female QTcF>470 milliseconds (msec); dizziness or vertigo with clinical significance and requiring medical intervention, or history of inner ear diseases known to cause dizziness or vertigo; Insomnia, anxiety disorder, depression disorder or other mental disorders requiring medical intervention; Use any caffeinated food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the experimental drug, or disagree with the prohibition of using any caffeinated food or drink during the trial; Suffering from or having suffered from major diseases of cardiovascular system, respiratory system, digestive system, urinary system, hematology, endocrine system, immunity system, skin system or nervous system, including acute diseases or major surgical operations within 3 months before screening; Suffering from or having suffered from diseases of gastrointestinal tract, liver, kidney or other known diseases that interfere with drug absorption, distribution, metabolism or excretion; Blood donation or blood loss of ≥400 mL or more within 3 months before the first administration of the experimental drug; Any drugs that inhibit or induce liver drug metabolizing enzymes have been used within 28 days before the first administration of experimental drugs (such as barbiturates, carbamazepine, phenytoin, glucocorticoid and omeprazole; Inhibitor serotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines), or any prescription drugs, over-the-counter drugs, Chinese patent medicines and herbs other than the above drugs were taken orally within 14 days before the administration of the experimental drugs; have participated in clinical trials of other drugs within 3 months before the first administration of experimental drugs; Use any live vaccine within 28 days before the first administration of experimental drugs; At present, they are or have been drug users, or they are positive in drug abuse screening (screening items include: morphine, tetrahydrocannabinol, methamphetamine, methylenedioxyamphetamine, ketamine and cocaine); Regular drinkers within 3 months before the first administration of the experimental drug, that is, those who drink more than 14 units of alcohol per week (1 unit =10g pure alcohol, or 285mL beer [4.9% Alc./Vol] or 30 mL spirits [40% Alc./Vol] or 100 mL wine [12% Alc./Vol]), or the alcohol breath test is positive; Smoking more than 5 cigarettes per day (or using a considerable amount of nicotine-containing products) within 3 months before the first administration of experimental drugs, or failing to comply with the smoking ban during the trial; One or more of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody are positive during the screening period; Have any history of malignant tumor in recent 10 years; pregnant or lactating women; The estimated glomerular filtration rate (eGFR) during the screening period is clinically significant or has a history of kidney calculi's disease and kidney disease; Subjects with poor compliance or other factors that are not suitable for participating in this experiment.

Sites / Locations

  • Beijing Jishuitan HoispitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A1

A2

B1

B2

Arm Description

Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of probenecid on D2.

Period 1: HSK16149 single dose on D2, 40mg, fasted;probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of Probenecid on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted;

Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2.

Period 1: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted;

Outcomes

Primary Outcome Measures

Cmax
The maximun plasma concentration of HSK16149
AUC0-t
Area under the concentration-time curve from time zero to time of last quantifiable concentration
AUC0-inf
Area under the concentration-time curve from time zero extrapolated to infinite time

Secondary Outcome Measures

Tmax
Time of maximum concentration
t1/2
half life
Vz
Volume of distribution associated with the terminal phase
CL
Plasma clearance
Ae
Cumulative urinary recovery of unchanged drug
Fe
Cumulative urinary recovery fraction of unchanged drug
CLr
Renal clearance

Full Information

First Posted
May 16, 2023
Last Updated
June 14, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05881811
Brief Title
The Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects
Official Title
An Open-label Phase I Study to Evaluate the Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
June 22, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group 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
This study is a single-center, open-label, crossover study, conducted in healthy Chinese populations, and plans to enroll 48 healthy adult subjects (male and female).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PHN - Post-Herpetic Neuritis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Description
Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of probenecid on D2.
Arm Title
A2
Arm Type
Experimental
Arm Description
Period 1: HSK16149 single dose on D2, 40mg, fasted;probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of Probenecid on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted;
Arm Title
B1
Arm Type
Experimental
Arm Description
Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2.
Arm Title
B2
Arm Type
Experimental
Arm Description
Period 1: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted;
Intervention Type
Drug
Intervention Name(s)
HSK16149,probenecid, cimetidine
Intervention Description
40mg HSK16149 single dose, fasted; 500mg probenecid QID from D1~D4 200mg cimetidine QID from D1~D4
Primary Outcome Measure Information:
Title
Cmax
Description
The maximun plasma concentration of HSK16149
Time Frame
From the start to 72 hours after administration
Title
AUC0-t
Description
Area under the concentration-time curve from time zero to time of last quantifiable concentration
Time Frame
From the start to 72 hours after administration
Title
AUC0-inf
Description
Area under the concentration-time curve from time zero extrapolated to infinite time
Time Frame
From the start to 72 hours after administration
Secondary Outcome Measure Information:
Title
Tmax
Description
Time of maximum concentration
Time Frame
From the start to 72 hours after administration
Title
t1/2
Description
half life
Time Frame
From the start to 72 hours after administration
Title
Vz
Description
Volume of distribution associated with the terminal phase
Time Frame
From the start to 72 hours after administration
Title
CL
Description
Plasma clearance
Time Frame
From the start to 72 hours after administration
Title
Ae
Description
Cumulative urinary recovery of unchanged drug
Time Frame
From the start to 72 hours after administration
Title
Fe
Description
Cumulative urinary recovery fraction of unchanged drug
Time Frame
From the start to 72 hours after administration
Title
CLr
Description
Renal clearance
Time Frame
From the start to 72 hours after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 50 years (inclusive), male and female; Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-28 kg/m2 (inclusive); Physical examination, vital sign measurements results were deemed appropriate by the investigator; Not in use of any drug within 2 weeks prior to screening; 7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration. Exclusion Criteria: Have an allergic history to the main ingredients and/or any auxiliary materials in the research preparation, allergic diseases or allergies, or allergic history to pregabalin or gabapentin, or allergic history to pregabalin or gabapentin or sulfonamides; Have special requirements for diet and cannot follow the unified diet; The abnormal results of 12-lead electrocardiogram (ECG), chest X-ray (positive position) and routine laboratory tests (blood routine, blood biochemistry, urine routine and coagulation function) during the screening period have clinical significance and are judged by the researchers to be unsuitable to participate in this experiment; In the screening period, male QTcF>450 milliseconds (msec) and female QTcF>470 milliseconds (msec); dizziness or vertigo with clinical significance and requiring medical intervention, or history of inner ear diseases known to cause dizziness or vertigo; Insomnia, anxiety disorder, depression disorder or other mental disorders requiring medical intervention; Use any caffeinated food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the experimental drug, or disagree with the prohibition of using any caffeinated food or drink during the trial; Suffering from or having suffered from major diseases of cardiovascular system, respiratory system, digestive system, urinary system, hematology, endocrine system, immunity system, skin system or nervous system, including acute diseases or major surgical operations within 3 months before screening; Suffering from or having suffered from diseases of gastrointestinal tract, liver, kidney or other known diseases that interfere with drug absorption, distribution, metabolism or excretion; Blood donation or blood loss of ≥400 mL or more within 3 months before the first administration of the experimental drug; Any drugs that inhibit or induce liver drug metabolizing enzymes have been used within 28 days before the first administration of experimental drugs (such as barbiturates, carbamazepine, phenytoin, glucocorticoid and omeprazole; Inhibitor serotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines), or any prescription drugs, over-the-counter drugs, Chinese patent medicines and herbs other than the above drugs were taken orally within 14 days before the administration of the experimental drugs; have participated in clinical trials of other drugs within 3 months before the first administration of experimental drugs; Use any live vaccine within 28 days before the first administration of experimental drugs; At present, they are or have been drug users, or they are positive in drug abuse screening (screening items include: morphine, tetrahydrocannabinol, methamphetamine, methylenedioxyamphetamine, ketamine and cocaine); Regular drinkers within 3 months before the first administration of the experimental drug, that is, those who drink more than 14 units of alcohol per week (1 unit =10g pure alcohol, or 285mL beer [4.9% Alc./Vol] or 30 mL spirits [40% Alc./Vol] or 100 mL wine [12% Alc./Vol]), or the alcohol breath test is positive; Smoking more than 5 cigarettes per day (or using a considerable amount of nicotine-containing products) within 3 months before the first administration of experimental drugs, or failing to comply with the smoking ban during the trial; One or more of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody are positive during the screening period; Have any history of malignant tumor in recent 10 years; pregnant or lactating women; The estimated glomerular filtration rate (eGFR) during the screening period is clinically significant or has a history of kidney calculi's disease and kidney disease; Subjects with poor compliance or other factors that are not suitable for participating in this experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meixia Wang, PhD
Phone
010-58517124
Email
wangmeixiad@163.com
Facility Information:
Facility Name
Beijing Jishuitan Hoispital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meixia Wang
Phone
010-58517124
Email
wangmeixiad@163.com

12. IPD Sharing Statement

Learn more about this trial

The Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects

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