Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Healthy
Interventions
DRUG

Methosulide

"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)"

DRUG

Placebo

Placebo to match with experimental groups

Trial Locations (1)

Unknown

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan,Hubei

All Listed Sponsors
collaborator

Academy Military Medical Science, China

INDUSTRY

lead

Hubei Biological Medicine Industrial Technology Institute Co., Ltd.

OTHER

NCT02374684 - Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects | Biotech Hunter | Biotech Hunter