CompletedPhase 1

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

China47 participantsStarted 2023-03-20

Plain-language 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).

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

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；

What they're measuring

Cmax

Timeframe: From the start to 72 hours after administration

AUC0-t

Timeframe: From the start to 72 hours after administration

AUC0-inf

Timeframe: From the start to 72 hours after administration

Trial details

NCT IDNCT05881811

SponsorHaisco Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-24

View on ClinicalTrials.gov More PHN - Post-Herpetic Neuritis trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

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；