Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorValenta Pharm JSC

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

Treatment groups

45 Participants
are divided into 3 treatment groups

Sponsors and collaborators