It is used to prevent nausea and vomiting caused by moderate and/or highly emetogenic chemotherapy that requires continuous administration for 3 to 5 days.
Conditions
Interventions
RT Group:The first cycle test preparation (T), the outer left/right upper arm, and the second cycle reference preparation (R, Shankeshu ?), the lateral right/left upper arm
TR Group:The first cycle reference preparation (R, Sankeshu ?), the outer left/right upper arm, and the second cycle test preparation (T), the outer right/left upper arm
Sponsors
The Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who can understand and are willing to follow the clinical trial protocol to complete this trial and sign the informed consent form; 2.The subjects were male and female individuals aged between 18 and 65 years old (including those aged 18 and 65), with an appropriate ratio of males to females; 3.Male participants had a body weight of 50 kg or more, and female participants had a body weight of 45 kg or more; the body mass index was within the range of 19.0 to 26.0 kg/m2 (including the critical value); 4.The health condition is good. There is no history of serious diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, musculoskeletal system, or mental disorders; 5. The subjects (including male subjects) guarantee that they have no plans for conception or sperm/egg donation from the two weeks prior to screening until three months after the last administration, and that they have voluntarily taken appropriate contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Those who have had an allergic reaction to granisetron or selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists or any other ingredients; those who are allergic to two or more substances (dust, pollen, food, drugs, etc.); those who are allergic to medical tapes, adhesive dressings or other skin patches; 2. For those who are allergic to the application site of cosmetics or sunlight, or who cannot tolerate physical shading of the application site within 10 days after the administration (such as being shielded by clothes or going out with an umbrella); 3. Previous history of skin disorders such as atopic dermatitis, psoriasis, vitiligo or any known conditions that alter the appearance or physiological response of the skin (e.g. diabetes, porphyria); 4. There are open wounds on the outer side of the upper arm, or the skin is red, irritated or damaged, or the skin color between the two arms is significantly different, or there are situations that affect the adhesion of the medicine, the evaluation of the skin, or the absorption of the medicine (such as excessive hair, scar tissue, tattoos, abnormal skin color, etc.); 5.Exclude those who have used liver enzyme inhibitors or inducers within the previous 30 days (such as CYP3A4 inhibitors like itraconazole, ketoconazole, ritonavir, clarithromycin, erythromycin, verapamil, fluvoxamine; CYP3A4 inducers like carbamazepine, phenytoin, phenobarbital). 6. Exclude those who have used serotonergic drugs within the past 14 days (such as selective serotonin reuptake inhibitors [SSRIs, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and escitalopram, etc.], serotonin and norepinephrine reuptake inhibitors [SNRIs, including venlafaxine and duloxetine, etc.], monoamine oxidase inhibitors [representing drugs such as isoniazid, isopropranol, phenylpropranol, safenamide, tololaxone, mirtazapine and reselectin, etc.], mirtazapine); 7.Those who have special dietary requirements and cannot accept the uniform diet; 8. Those who cannot tolerate venipuncture or have a history of fainting or experiencing bleeding during injections; 9.Those whose physical examination results, vital sign monitoring, 12-lead electrocardiogram, and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function) show abnormal results and are considered clinically significant by the researchers; 10.Any abnormality in the hepatitis B virus surface antigen, syphilis spirochete specific antibody, human immunodeficiency virus antibody, or hepatitis C virus antibody is of clinical significance; 11. Select those who have consumed alcohol frequently within the past 3 months, that is, those who have consumed more than 14 units of alcohol on average per week (1 unit ˜ 360ml of beer or 45ml of 40% alcohol spirits or 150ml of wine), or those whose alcohol breath test result is > 0mg/100ml; 12. Those who had smoked more than 5 cigarettes per day for the previous 3 months, or those who were unable to stop using any tobacco products during the trial; 13. Those who participated in any clinical trial within the past 3 months and received the trial medication, or those who plan to participate in other clinical trials during the trial period; 14. Those who have donated blood within the past 3 months, including those who have donated component blood or undergone significant blood loss (>= 400ml), those who have received blood transfusions or used blood products, and those who plan to donate blood duri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glasopren AUC0-t;Glasopren AUC0-8;Glasopren Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse events;Adverse events; | — |
Countries
China
Contacts
Public ContactZhihong Xie
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed