NCT02374684

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Hubei Biological Medicine Industrial Technology Institute Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-03-02
• Last updated: 2016-02-19

Locations

1 site across 1 country: China