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Medical: Cardiology
Medical: Pharmaceuticals
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Sample translations submitted: 1
Chinese to English: Drugs and Clinical Study General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Chinese 诊断和主要入选标准 将根据筛选期的实验室评价、人口统计学（年龄、身高、体重和BMI）、病史、临床检查以及生命体征、胸部X线检查（P/A视图）和ECG记录，选择年龄在18至45岁（含）之间（含18岁和45岁）的健康、不吸烟、自愿参加的男性志愿者。将在每个周期入院时进行滥用药物尿液筛查和呼气酒精含量检测。
Translation - English Diagnosis and Main Inclusion Criteria A selection of healthy, non-smoking, voluntary male volunteers between the ages of 18 and 45 years (inclusive) will be conducted based on laboratory evaluation, demographics (age, height, weight, and BMI), medical history, clinical examination, vital signs, chest x-ray (PA projections), and ECG records during the screening period. Urine screening for drug abuse and breath alcohol test will be performed at each period of admission.
Inclusion Criteria:
• Healthy, non-smoking male subjects between the ages of 18 and 45 years (inclusive).
• Subjects with a BMI of 18.50 to 30.00 kg/m2 (including 18.50 and 30.00 kg/m2) and weighing at least 50.00 kg.
• Subjects in normal health as determined by clinically acceptable and confirmatory results of personal medical history, clinical examination, including vital signs in combination with laboratory tests (which include serology tests).
• Subjects with normal or non-clinically significant 12-lead electrocardiogram (ECG) records.
• Subjects with a normal or non-clinically significant chest x-ray (PA projections).
• Negative urine screening for drug abuse results (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Negative breath alcohol test results.
• Subjects who are willing to comply with the requirements of the study protocol and provide informed consent form.
• Subjects who can provide sufficient evidence of their identities.
• Volunteers available throughout the study period.
• If the subject feels drowsy, sedated, dizzy, in a state of confusion, or has blurred vision after administration of the study drug, he or she agrees not to drive or operate machinery until full mental alertness is restored.
• Subjects will be able to fast for at least 14.00 h and consume a standard meal.
Pharmacokinetics Parameters The following pharmacokinetic parameters will be calculated using Phoenix WinNonlin 7.0 or higher (Phoenix 1.3) based on the predicted concentration-time curve of trazodone.
Primary pharmacokinetics parameters: Cmax, AUC0-t, and AUC0-ꝏ.
Secondary pharmacokinetics parameters: AUC0-24h, Tmax, t1/2, Kel and projected AUC.
To determine whether drug accumulation is possible, the ratio (%) of mean AUC0-24h/mean AUC0-ꝏ will be calculated for the test product and reference product.
Drug accumulation is considered unlikely if the ratio of mean AUC0-24h/mean AUC0-ꝏ for the test and reference products is >90%. In this case, early and end-stage pAUC will be calculated. These two pAUCs (early and end-stage) will be one time point apart, which is half the dosing interval of the study product.
Half of the dosing interval of 150 mg of trazodone hydrochloride extended-release tablets = t/2 = 24 h/2 = 12 h
Therefore, the early-stage pAUC refers to AUC0-12h and the end-stage pAUC refers to AUC12h-t.
If the ratio of mean AUC0-24h/mean AUC0-ꝏ of the test and reference products is ≤ 90%, they are likely potential drug accumulation. In this case, there is no need to calculate early and end-stage pAUC. Multiple dosing study designs will follow.
Bioequivalence
Criteria Bioequivalence assessment will be based on 90% confidence intervals of least squares mean differences for the log-transformed Cmax, AUC0-t and AUC0-ꝏ of trazodone obtained after a single dose in fasting.
The acceptance criteria for bioequivalence is that the entire confidence interval of mean differences for log-transformed Cmax, AUC0-t, and AUC0-ꝏ should be in the range of 80.00–125.00%.
If it is demonstrated that drug accumulation is unlikely after a single dose, evidence of bioequivalence will also be based on other pharmacokinetic parameters identified as pAUC, i.e., AUC0-12h and AUC12h-t.
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Years of experience: 6. Registered at ProZ.com: Sep 2022.
My name is Daqing Xie. I am a licensed urologist and a freelance translator from China.
I have 4 years of experience translating between Chinese (Simplified) and English.
I have a Master's Degree in surgery, and my areas of expertise include tumors of the urinary system and molecular biology. I also have experience in game localization.
In addition, I am skilled in CAT tools like Trados Studio and MemoQ.
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