Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects
- Registration Number
- NCT03905291
- Lead Sponsor
- Medy-Tox
- Brief Summary
To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Adults aged between 20 and 65 years
- Subject not appropriate for participating in this study according to the investigator's opinion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT921 120mg Group MT921 MT921 120 mg Placebo Group Placebo Placebo MT921 60mg Group MT921 MT921 60 mg MT921 150mg Group MT921 MT921 150 mg
- Primary Outcome Measures
Name Time Method Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) Up to 24 hours Peak plasma concentration measured by Liquid Chromatography-mass spectrometry (LC/MS) achieving in the test area of the body after administration.
AUC0-24 Up to 24 hours Area under the plasma concentration versus time curve from time 0 to 24 hours measured by Liquid Chromatography-mass spectrometry (LC/MS) after administration
Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) Up to 24 hours The time at which the Cmax is observed measured by Liquid Chromatography-mass spectrometry (LC/MS).
Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS) Up to 24 hours The time it takes for the concentration of the drug in the plasma or the total amount in the body to be reduced by 50% measured by Liquid Chromatography-mass spectrometry (LC/MS).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Anam Hospital
🇰🇷Seoul, Korea, Republic of