MedTrace Logo

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

NCT02374684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2016-02-19

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Academy Military Medical Science, China

    collaborator INDUSTRY

  • Hubei Biological Medicine Industrial Technology Institute Co., Ltd.

    lead OTHER

Principal Investigators

  • ZHENG Heng · Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • China

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374684 on ClinicalTrials.gov