Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan,Hubei, China
NCT Number: NCT02374684
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Wuhan,Hubei, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Other names: CM2010-01
Placebo to match with experimental groups
Time frame: Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days
Adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment
Time frame: Baseline - 7 Days
Time frame: Baseline - 7 Days
Time frame: Baseline - 7 Days
Time frame: Baseline - 7 Days
Time frame: Baseline - 7 Days
Time frame: Baseline - 7 Days
Time frame: Baseline - 7 Days
Time frame: Baseline - 14 Days
Time frame: Baseline - 14 Days
Time frame: Baseline - 14 Days
Time frame: Baseline - 14 Days
Time frame: Baseline - 14 Days
Time frame: Baseline - 14 Days
Time frame: Baseline - 14 Days
Time frame: Baseline - 14 Days
Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
Other
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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