Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Ta… (NCT07421011) | Clinical Trial Compass
RecruitingPhase 1
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
Russia36 participantsStarted 2025-11-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
. Heart rate (HR) from 60 to 89 beats per minute (inclusive);
. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics - Cmax
Timeframe: From 0 to 48 hours after each drug intake.
2
Pharmacokinetics - tmax
Timeframe: From 0 to 48 hours after each drug intake.
3
Pharmacokinetics - AUC0-t
Timeframe: From 0 to 48 hours after each drug intake.
4
Pharmacokinetics - AUC0-inf
Timeframe: From 0 to 48 hours after each drug intake.
5
Pharmacokinetics - AUCextr
Timeframe: From 0 to 48 hours after each drug intake.
6
Pharmacokinetics - t1/2
Timeframe: From 0 to 48 hours after each drug intake.
7
Pharmacokinetics - kel
Timeframe: From 0 to 48 hours after each drug intake.
. Body temperature from 36.0°C to 36.9°C (inclusive);
. Body mass index (BMI) between 18.5 kg/m² and 30 kg/m², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women;
Exclusion criteria
. 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;
. Development of a severe and/or serios adverse event (AE/SAE) in the volunteer during the study;
. The volunteer undergoes or requires treatment that may affect the pharmacokinetic parameters (PKP) of the investigational drugs;
. Missed collection of 2 or more consecutive blood samples or 3 or more blood samples within one study period;
. Occurrence of vomiting/diarrhea within 6 hours after taking the investigational drug;
Pharmacokinetics - MRT
Timeframe: From 0 to 48 hours after each drug intake.
9
Pharmacokinetics - Vd
Timeframe: From 0 to 48 hours after each drug intake.
10
Pharmacokinetics - CL
Timeframe: From 0 to 48 hours after each drug intake.
11
Pharmacokinetics - number of terminal timepoints
Timeframe: From 0 to 24 hours after each drug intake.