Study Population
Healthy Chinese subjects age 18 and over, with body mass index (BMI)
between 19.0 and 28.0 kg/m2 were eligible for
recruitment. Subjects needed to be in good health as determined by
medical history, 12-lead ECG, vital signs, physical examination and
laboratory tests (hematology, blood biochemistry, blood pregnancy test,
urinalysis, virological screening, alcohol breath test and other drugs
of abuse) and nonsmoking status. Subjects were not allowed to take any
medications or supplements throughout the study. To avoid hypertensive
crisis , a diet rich in tyramine such as wine and cheese, was
prohibited. Eligible subjects did not have concomitant conditions or
treatments that could have interfered with the study or interpretation
of its results. Women of childbearing age were eligible if they had a
negative serum pregnancy test and were willing to use consistent and
acceptable contraception for the duration of the study. Male subjects
also agreed to use acceptable contraception during the study and for 6
months after the study administration. Enrolled subjects should not have
participated in another clinical trial in the last 3 months.