Last updated: April 19, 2022
Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting
Phase
1
Condition
Healthy Volunteers
Treatment
N/AClinical Study ID
NCT05345964
GST-HG151-I-01
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Sign the informed consent before the trial and fully understand the content, processand possible adverse reactions of the trial.
- Subjects (including partners) are willing to take effective pregnancy avoidancemeasures within 6 months after screening to the last study drug administration.
- Male and female healthy subjects aged 18 to 45 years (including 18 and 45 years old).
- Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg.Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in therange of 19 ~ 24 kg / m2 (including critical value).
- Good physical condition (no significant clinical symptoms, normal physicalexamination. no clinically significant of laboratory examination, vital signs, 12 leadECG, chest film and abdominal B-ultrasound results).
Exclusion
Exclusion Criteria:
- Allergic constitution (allergic to a variety of drugs, especially ingredients similarto the test drug, or excipients of the test drug, or food).
- Smokers or those who smoke more than 5 cigarettes per day in the three months beforescreening, or disagree to avoid using any tobacco products during the study.
- Have a history of alcoholism or drink regularly in the three months before screening,those who drink more than 14 units of alcohol per week (1 unit = 360ml of beer with 5%alcohol content or 45ml of spirits with 40% alcohol content or 150ml of wine with 12%alcohol content). Who cannot stop alcohol intake during the study or have a positivebreath test for alcoho.
- Blood donation or massive blood loss (≥300 mL, , except female menstruation) or useblood products or blood transfusion within 3 months before screening.
- Have special requirements for diet and cannot abide by the unified diet.
- Took any prescription drugs, over-the-counter drugs, health products or Chinese herbalmedicine within 2 weeks before screening.
- Have taken the study drug or participated in the drug clinical trial within threemonths before taking the study drug(Except for those who did not enter the group).
- Take any drugs that alter liver enzyme activity CYP3A4, including strong inhibitorsand inducers that affect CYP3A4, within 28 days before screening or during the study.
- Female subjects were breastfeeding during the screening period or during the trial orwere preparing for pregnancy recently or had a positive serum pregnancy result.
- Have been smoking,drinking,or Ingested tea, any caffeinated or xanthine-rich food ordrink,or special diet (including dragon fruit, mango, grapefruit, etc.),or havevigorous exercise, or have other factors affecting drug absorption, distribution,metabolism, excretion, etc.within 48hours before screening.
- Ingested chocolate,any alcohol-containing product within 24 hours before screening.
- Subjects who cannot tolerate the standard meal (high fat and high calorie meal) (thisstrip is only applicable to subjects participating in the food impact study).
- Have a history of dysphagia or any gastrointestinal disease that affects drugabsorption.
- Clinical laboratory examinations are abnormal and clinically significant, or thefollowing diseases (including but not limited to gastrointestinal tract, kidney,liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovasculardisease).
- HBsAg, HCV, HIV and TPPA have one or more positive.
- had undergone major surgery within 4 weeks before screening or planned surgery duringthe trial.
- Have a history of drug abuse, or have used drugs within 3 months before screening, orthose who are positive in the screening test of urine drugs and drugs (methamphetamine, tetrahydrocannabinol acid, ketamine, cocaine, benzodiazepine,dimethylbisoxyamphetamine and morphine).
- Have difficulty in blood collection, or have a history of needle fainting or cannottolerate venipuncture.
- Cannot complete the trial for other reasons, or the investigator believes should notbe included.
Study Design
Total Participants: 112
Study Start date:
March 07, 2022
Estimated Completion Date:
May 31, 2023
Study Description
Connect with a study center
Mengchao Hepatpbiliary Hospital of Fujian Medical University
Fujian, Fuzhou 350025
ChinaActive - Recruiting
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