An Open-label Phase I Study to Evaluate the Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- HSK16149，probenecid, cimetidine
- Conditions
- PHN - Post-Herpetic Neuritis
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- AUC0-t
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
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;
- •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;
Arms & Interventions
A1
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.
Intervention: HSK16149，probenecid, cimetidine
A2
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;
Intervention: HSK16149，probenecid, cimetidine
B1
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.
Intervention: HSK16149，probenecid, cimetidine
B2
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: HSK16149，probenecid, cimetidine
Outcomes
Primary Outcomes
AUC0-t
Time Frame: From the start to 72 hours after administration
Area under the concentration-time curve from time zero to time of last quantifiable concentration
AUC0-inf
Time Frame: From the start to 72 hours after administration
Area under the concentration-time curve from time zero extrapolated to infinite time
Cmax
Time Frame: From the start to 72 hours after administration
The maximun plasma concentration of HSK16149
Secondary Outcomes
- Tmax(From the start to 72 hours after administration)
- t1/2(From the start to 72 hours after administration)
- Vz(From the start to 72 hours after administration)
- CL(From the start to 72 hours after administration)
- Ae(From the start to 72 hours after administration)
- Fe(From the start to 72 hours after administration)
- CLr(From the start to 72 hours after administration)