Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects
- Registration Number
- NCT02374684
- Lead Sponsor
- Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
- Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～25 kg/m2, Weight > or = 50kg
- In good health as judged by the investigator
- Without history of medication within 2 weeks before the test
- Non-allergic constitution, without known drug allergy
- Without history of major organ diseases
- Without other factors affecting drug metabolism, such as smoking (within 2 weeks), drinking (within 2 weeks), or drug abuse history
- Signed informed consent form and Fully understood the contents, process and possible adverse reactions of the test
Exclusion Criteria
- History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution
- Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: blood system, renal disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, allergic diseases (including drug allergy, but not including non-treatment, asymptomatic, seasonal allergy during the period of oral administration)
- History of abuse of Smoking, alcohol, or other drugs
- Severe hemorrhage factors to affect the venous blood collection
- Severe blood loss or blood donation within 3 months before the test
- Participation in other drug trials within 3 months before the test
- Usage of drugs known to have damage to the main organs within 3 months before the test
- Without good compliance, or unable to match with the test
- with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected
- For childbearing-aged women only, usage of any hormonal contraceptive methods within 3 months before the drug administration; or unable or unwilling to use non-hormonal contraceptive methods to contraception from the day of dosing until 14 days after dosing
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, oral administration Methosulide Methosulide Methosulide, oral administration
- Primary Outcome Measures
Name Time Method 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. 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
- Secondary Outcome Measures
Name Time Method Cmax of single oral administration of Methosulide and effect of food in healthy adults. Baseline - 7 Days Tmax of single oral administration of Methosulide and effect of food in healthy adults. Baseline - 7 Days area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults. Baseline - 7 Days t1/2α of single oral administration of Methosulide and effect of food in healthy adults. Baseline - 7 Days t1/2β of single oral administration of Methosulide and effect of food in healthy adults. Baseline - 7 Days Vd of single oral administration of Methosulide and effect of food in healthy adults. Baseline - 7 Days Cls of single oral administration of Methosulide and effect of food in healthy adults. Baseline - 7 Days Css of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days Cmax of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days Tmax of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days area under curve(AUC) of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days t1/2α of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days Vd of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days Cls of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days t1/2β of repeated oral administration of Methosulide in healthy adults. Baseline - 14 Days
Trial Locations
- Locations (1)
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan，Hubei, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology🇨🇳Wuhan，Hubei, China