15 stable patients diagnosed with schizophrenia take 100 mg of VLT-015 once a day, 200 mg of VLT-015 once a day and 200 mg of VLT-015 on two consecutive days with an interval of 24 hours between doses. PK parameters are measured, tolerability and safety of the product are evaluated.
At stage 1, 15 stable patients diagnosed with schizophrenia take 1 tablet of VLT-015 (100 mg) followed by blood sampling to measure the level of the active substance and its main metabolite within 72 hours. After that patients have 3 days washout period. At the second stage, the same 15 patients take two 100 mg tablets of VLT-015 (200 mg) followed by blood sampling to measure the level of the active substance and its main metabolite within 72 hours. Then patients have the same 3 days washout period. At stage 3, the same patients take 2 tablets of VLT-015 (200 mg) consecutively for 2 days with 24-hours interval followed by blood sampling to measure the level of the active substance and its main metabolite within 96 hours. PK parameters are measured, tolerability and safety of the product are evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
100 mg single dose, 200 mg single dose, 200 mg single dose once a day for two consecutive days
Federal State Budgetary Scientific Institution "Mental Health Research Centre"
Moscow, Moscow Oblast, Russia
GBUZ SK Stavropol Regional Clinical Specialized Psychiatric Hospital No. 1
Stavropol, Stavropol Oblast, Russia
Cmax
Maximum plasma concentration
Time frame: 3 weeks
Tmax
Time to reach the maximum concentration
Time frame: 3 weeks
AUC o-t
Area under the pharmacokinetic curve, starting from time zero until the time of last blood sample collection
Time frame: 3 weeks
AUC o - ∞
Area under the pharmacokinetic curve, starting from time zero to infinity
Time frame: 3 weeks
AUC o-t/AUC o-∞
Share of AUC o-t of AUC o-∞ expressed in %
Time frame: 3 weeks
T1/2
Half-life, determined by the formula T\_(1/2)= (ln(2))/K\_el
Time frame: 3 weeks
MRT
Mean retention time of the drug in the body, calculated from the start of the first time point to the time the last blood sample was taken
Time frame: 3 weeks
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