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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
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
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan,Hubei, China
Safety and tolerability of single and repeated oral administration of Methosulide as measured by the frequency of drug-related clinical adverse events in healthy adults.
Adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment
Time frame: Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days
Cmax of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Tmax of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
t1/2α of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
t1/2β of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Vd of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Cls of single oral administration of Methosulide and effect of food in healthy adults.
Time frame: Baseline - 7 Days
Css of repeated oral administration of Methosulide in healthy adults.
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Time frame: Baseline - 14 Days
Cmax of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Tmax of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
area under curve(AUC) of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
t1/2α of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
t1/2β of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Vd of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days
Cls of repeated oral administration of Methosulide in healthy adults.
Time frame: Baseline - 14 Days