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Chinese to English: clinical trial protocol General field: Medical
Source text - Chinese 受试者：筛选健康男性志愿者参加本研究，研究中受试者的入选和排除标准在以下部分列出。
Translation - English Trial procedures:
Test under fast conditions:
Subject screening and physical examination: Subjects are asked to complete the following procedures within one week prior to the initiation of the trial: signing of informed consent form, questioning for taking medical history (medical history, history of allergies, history of medications, history of participation in clinical trials, history of blood donation, history of drinking tea and coffee or caffeinated beverages, smoking, alcohol drinking, history of drug abuse), demographic data, vital signs (blood pressure, pulse, body temperature), physical examination, ECG, blood routine test, urine routine test, blood biochemistry, blood transfusion (4 items), drug abuse screen test, and alcohol breath test, etc.
Subject screening: Subjects are screened according to inclusion and exclusion criteria.
Hospitalization and randomization: Eligible subjects are admitted to phase I wards on the evening before the initiation of the trial and subject to the measurement of vital signs and alcohol breath test for the examinations based on the inclusion and exclusion criteria. Those meeting the requirements are subsequently randomized into different groups, with the details indicated in the randomization table.
Administration: After the subjects have been fasted for at least 10 hours, they are asked to take the test drug (T) or the reference (R) 4 mg with 240 ml of warm water in one single time under the fasted conditions on the morning of the day of the trial, during which they shall remain seated. The subjects shall maintain a sitting position during the entire administration process, which shall be completed under the supervision of trained staffs, and investigators shall examine the subject's hands and mouth.
Bachelor's degree - Nanjing University of Traditional Chinese Medicine
Years of translation experience: 8. Registered at ProZ.com: Sep 2015.