About this trial
This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.
Eligibility criteria
Qualifiers
Voluntary, personally signed ICF obtained prior to any study procedures;
Males and females aged 18 to 45 years (inclusive) of Caucasian race;
Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified in the protocol;
Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive);
Disqualifiers
Voluntary withdrawal of the subject from the study;
Failure to comply with protocol requirements by the volunteer (e.g., missing scheduled study procedures, unauthorized use of prohibited medications, or violation of dietary or lifestyle restrictions);
Occurrence of any event or condition during the study that, in the investigator's judgement, may compromise the volunteer's safety (e.g., hypersensitivity reactions);
Volunteers selected for participation in the study in violation of the inclusion/non-inclusion criteria;
Trial design
Treatments tested in this trial
- 4-MUST