Title
Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects
A Within-group Randomized, Double-Blind, Placebo-Controlled, Single/ Multiple Dose Study to Assess the Safety , Tolerability, Pharmacokinetics and Food Effect of Methosulide After Oral Administration In Healthy Adult Subjects.
Phase
Phase 1Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HealthyIntervention/Treatment
methosulide ...Study Participants
92The 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.
Dose-escalation study of single oral administration of Methosulide in healthy adults to assess the safety and tolerability.
Multiple-dose study of Methosulide in healthy adults to assess the safety and tolerability.
Dose-escalation study of single oral administration of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics
Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics characteristics
Single dose,and cross-over study of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics and effect of food.
Tolerability Study: Period I:Single oral administration,dose-escalation of Methosulide(six dose groups:25mg-250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg) Pharmacokinetic Study: Period I:Single oral administration,dose-escalation of Methosulide(three dose groups:50mg,100mg,200mg/250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg) Food Effect on the Pharmacokinetics: single dose(100mg),two status(Feeding and fasting), washout period(7 days)
Placebo to match with experimental groups
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.
