Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects
Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects
The purpose of this study is to determine the safety and tolerability, and to evaluate the
 pharmacokinetic characteristics and food effect of Methosulide after oral administration in
 healthy adult subjects.
1. Dose-escalation study of single oral administration of Methosulide in healthy adults to
 assess the safety and tolerability.

 2. Multiple-dose study of Methosulide in healthy adults to assess the safety and
 tolerability.

 3. Dose-escalation study of single oral administration of Methosulide in healthy adults to
 evaluate the pharmacokinetic characteristics

 4. Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics
 characteristics

 5. Single dose,and cross-over study of Methosulide in healthy adults to evaluate the
 pharmacokinetic characteristics and effect of food.
Inclusion Criteria:

 -  Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～25
 kg/m2, Weight > or = 50kg

 -  In good health as judged by the investigator

 -  Without history of medication within 2 weeks before the test

 -  Non-allergic constitution, without known drug allergy

 -  Without history of major organ diseases

 -  Without other factors affecting drug metabolism, such as smoking (within 2 weeks),
 drinking (within 2 weeks), or drug abuse history

 -  Signed informed consent form and Fully understood the contents, process and possible
 adverse reactions of the test

 Exclusion Criteria:

 -  History of kinds of food or drug allergy, or suffering from allergic diseases or
 allergic constitution

 -  Presence (in screening stage) or history of the acute/chronic organic diseases or
 clinical manifestations: blood system, renal disease, endocrine system, respiratory
 system, digestive system, cardiovascular system, nervous system, mental disease,
 allergic diseases (including drug allergy, but not including non-treatment,
 asymptomatic, seasonal allergy during the period of oral administration)

 -  History of abuse of Smoking, alcohol, or other drugs

 -  Severe hemorrhage factors to affect the venous blood collection

 -  Severe blood loss or blood donation within 3 months before the test

 -  Participation in other drug trials within 3 months before the test

 -  Usage of drugs known to have damage to the main organs within 3 months before the test

 -  Without good compliance, or unable to match with the test

 -  with a clinically significant abnormality in routine serological detection: including
 Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus
 (HIV) infected

 -  For childbearing-aged women only, usage of any hormonal contraceptive methods within 3
 months before the drug administration; or unable or unwilling to use non-hormonal
 contraceptive methods to contraception from the day of dosing until 14 days after
 dosing

 -  Be otherwise unsuitable for the study, in the opinion of the Investigator.