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 range18 Years – 45 Years
SexALL
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);
✓. 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.);
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.
8
Pharmacokinetics - MRT
Timeframe: From 0 to 48 hours after each drug intake.