This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in healthy volunteers under fasted conditions.
Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;
Males and females aged 18 to 45 years (inclusive) of Caucasian race.;
Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical and instrumental examination, laboratory tests, and other diagnostic procedures specified in the protocol;
Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);
Withdrawal of the volunteer from further participation in the study;
Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);
Emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);
Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria;
Crossover
Trimedat®
DrugA single dose of R or T drug in each of 2 periods of the study under fasted conditions
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of N-desmethyltrimebutine (main metabolite of trimebutine)
Pharmacokinetics - tmax
Time to reach Cmax (tmax)
Pharmacokinetics - AUC0-t
Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Pharmacokinetics - AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Adverse event type
Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.
Adverse event number
Number of adverse events registered during the study
Adverse event severety
Severity of adverse events registered during the study
Drop-outs associated with adverse events
The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug
Volunteer complaints
Description of complaints, recieved from volunteer
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