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Pharmacokinetic and Safety Study of ZSP1273 Tablets in Elderly and Young Subjects

Pharmacokinetic and Safety Study of ZSP1273 Tablets in Elderly and Young Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093920
Enrollment
Unknown
Registered
2024-12-13
Start date
2023-09-01
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza (short for flu)

Interventions

Elderly subjects:ZSP1273 tablet
Young subjects:ZSP1273 tablet

Sponsors

Sir Run Run Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Sign the informed consent form before the trial, and fully understand the content, process and possible adverse effects of the trial. 2.Sign the informed consent form before the trial, and fully understand the content, process and possible adverse effects of the trial. 3.Male subjects weighing no less than 50 kilograms and female subjects weighing no less than 45 kilograms. Body mass index (BMI) weight (kg) / height^2 (m^2) ,Body mass index within the range of 19.0-28.0kg/m^2 (including the critical value); 4.All subjects should have a heart rate between 50-100 beats/minute (including borderline values) : Body temperature (ear temperature) between 35.7-37.5°C; 5.Youth subjects should also meet the following requirements: 1) The age range of the youth group is between 18 and 45 years old (including boundary values); 2) The systolic blood pressure of the youth group should be between 90-139 mmHg (including boundary values) and the diastolic blood pressure should be between 60-89 mmHg (including boundary values):; 6.Elderly subjects must also meet the following requirements: 1) aged 65 years or older (including 65 years) in the elderly group; 2) systolic blood pressure <170mmHg and/or diastolic blood pressure <110mmHg without antihypertensive medication, or systolic blood pressure <=160mmHg and/or diastolic blood pressure <=110mmHg after antihypertensive medication.

Exclusion criteria

Exclusion criteria: 1) Allergy (allergy to two or more drugs, especially ZSP1273 tablets, food allergy); 2) have a history of alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine) within 12 months prior to screening or do not agree to abstain from alcohol during the trial period: 3) have had a traumatic injury or major surgical procedure within 4 weeks prior to screening or plan to undergo a procedure during the study period 4) who have participated in another clinical trial or taken study medication within three months prior to screening; 5) cannot stop eating special diet (including dragon fruit, mango, grapefruit, citrus, chocolate, any caffeine-containing or xanthine-rich food or beverage, etc.) or strenuous exercise, or other factors affecting the absorption, distribution, metabolism, or excretion of the drug for 48h prior to the administration of the study drug; 6)Anyone who has consumed any alcohol-containing product within 24 hours prior to taking the study drug or has a positive breath test for alcohol; 7)Those who have donated blood or lost a significant amount of blood (>400 mL) or received blood products within three months prior to screening; 8) those with a history of drug or substance abuse, or a positive urine drug screen (morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid); 9)Those with a positive nucleic acid test for novel coronavirus; 10) Pregnant or breastfeeding women or those who have a positive pregnancy test. 11) Female subjects or male subjects whose partner is a woman of childbearing potential who are planning to have a child and/or donate sperm/eggs within 3 months of signing the informed consent form or who do not agree to complete abstinence, or who plan to use a method of contraception that is not approved by the investigator (unacceptable methods of contraception include: i. Cyclical abstinence or contraceptives such as ejaculation: ii. Pharmacological contraceptives such as oral contraceptives, contraceptive injections, contraceptive patches, subdermal implants, intrauterine hormonal devices, and localized contraceptives such as spermicides); 12)Those who have special dietary requirements and cannot comply with the uniform diet: 13)Those who smoked an average of >=5 cigarettes per day in the 6 months prior to screening or those who do not agree to abstain from smoking for the duration of the trial: 14)Those who cannot tolerate blood collection by venipuncture and/or have a history of blood or needle sickness: 15)Those who have been vaccinated within 3 months prior to screening or plan to be vaccinated during the trial; 16)Acute illness of clinical significance (as judged by the investigator) such as gastrointestinal illness, infection (e.g., respiratory or central nervous system infection) within 2 weeks prior to screening: 17) History of dysphagia or any gastrointestinal disorder that interferes with drug absorption; 18) In the investigator's judgment, the subject has any other condition that may interfere with the proper completion of the trial or with the evaluation of the study data, or is otherwise unsuitable for participation in this study. Young subjects need to be excluded if they meet any of the following exclusion criter

Design outcomes

Primary

MeasureTime frame
PK parameters: AUC, Cmax,Tmax,CL/F,t1/2;

Secondary

MeasureTime frame
security incident;

Countries

China

Contacts

Public ContactXiang Lu

Sir Run Run Hospital, Nanjing Medical University

luxiang66@njmu.edu.cn+86 25 87115599

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026