Actively Recruiting
A Randomized, Open-label, Crossover Study to Assess the Pharmacokinetics, Bioequivalence, and Safety of Trimedat® 76.95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers
Led by Valenta Pharm JSC · Updated on 2026-02-19
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic profile, safety, and bioequivalence of Trimedat® 76.95 mg orally disintegrating tablets compared to the reference Trimedat® 100 mg tablets in healthy volunteers under fasted conditions. This Phase 1 study includes adults aged 18 to 45 years who are healthy and of Caucasian race. The study is sponsored by Valenta Pharm JSC and addresses conditions such as irritable bowel syndrome, gallstone disease, GERD, biliary dyskinesia, and postcholecystectomy syndrome. Participants are randomly assigned to one of two groups in a crossover design. Group 1 will take a 100 mg Trimedat® tablet in the first period and a 76.95 mg orally disintegrating tablet in the second period. Group 2 will take these treatments in reverse order. Each participant receives a single dose of the assigned form under fasting conditions. The study monitors treatment sequences without masking or blinding. Volunteers undergo medical history reviews, physical exams, laboratory tests, and other diagnostic procedures to confirm health status before participation. Researchers will measure pharmacokinetic parameters such as maximum drug concentration (Cmax), time to reach maximum concentration (tmax), and drug clearance over 48 hours after drug intake. Safety is monitored throughout the study by tracking adverse events from screening to study completion. The total involvement includes initial screening, two dosing periods, and follow-up assessments lasting about 15 days.
CONDITIONS
Brief Title
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent as a healthy volunteer before any study procedures
- Male or female Caucasian adults aged 18 to 45 years inclusive
- Verified healthy status with no clinically significant abnormalities in medical history, physical exam, or lab tests
- Blood pressure with systolic 100 to 130 mm Hg and diastolic 70 to 89 mm Hg
- Heart rate between 60 and 89 beats per minute
- Respiratory rate between 12 and 20 breaths per minute
- Body temperature between 36.0�B0C and 36.9�B0C
- Body mass index between 18.5 and 30 kg/m�B2, with minimum weight �B5 55 kg for men and �B5 45 kg for women
- Agreement to use effective contraception during the study and for 30 days after, with negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Clinically significant allergy history
- Hypersensitivity or intolerance to active or inactive substances in the study drugs
- Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
- Chronic diseases affecting kidneys, liver, gastrointestinal tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, immune systems, skin, blood, or eyes
- Prior gastrointestinal surgery except appendectomy over 1 year ago
- Conditions affecting absorption or metabolism of study drugs
- Acute infections within 4 weeks before screening
- Use of drugs affecting hemodynamics or liver function within 2 months before screening
- Regular medication use within 2 weeks or single medication use within 7 days before screening
- Blood or plasma donation within 3 months before screening
- Use of hormonal contraceptives or depot injections within 2 to 3 months before screening
- Pregnancy, lactation, or positive pregnancy test
- Unprotected intercourse with unsterilized male partner within 30 days before dosing
- Participation in another clinical trial within 3 months before screening
- Alcohol consumption exceeding 10 units per week or history of substance abuse
- Smoking more than 10 cigarettes per day currently or in past 6 months
- Consumption of alcohol, caffeine, or certain foods and supplements within 7 days before dosing
- Dehydration within 24 hours before dosing
- Positive tests for HIV, hepatitis B or C, syphilis, narcotics, or alcohol during screening
- ECG abnormalities
- Planned hospitalization during the study except as specified
- Inability or unwillingness to follow protocol or dietary/activity restrictions
- Membership in vulnerable populations or conditions affecting consent or study adherence
- Other investigator-judged conditions that may prevent participation or cause withdrawal
- Withdrawal or non-compliance during the study
- Occurrence of adverse events or vomiting/diarrhea affecting drug absorption during the study
- Missed blood sample collections as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 days including both dosing periods
Participants receive a single dose of Trimedat® drug in each of 2 periods under fasted conditions to assess pharmacokinetics and bioequivalence.
2 dosing visits under fasted conditions with pharmacokinetic sampling up to 48 hours after each dose
Trial Site Locations
Total: 1 location
1
Federal Budgetary Institution of Science "North-West Public Health Research Center"
Saint Petersburg, Russia, 191036
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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