Actively Recruiting

Phase 1
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT07421011

Pharmacokinetics, Bioequivalence, and Safety Study 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

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study procedures
  • Male or female aged 18 to 45 years, Caucasian race
  • Verified healthy status with no significant medical abnormalities
  • Blood pressure: systolic 100 to 130 mm Hg, 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 36.06C and 36.96C
  • Body mass index between 18.5 and 30 kg/m8, with minimum weight  55 kg for men and  45 kg for women
  • Consent to use reliable contraception during the study and for 30 days after, with a negative pregnancy test for women of childbearing potential
Not Eligible

You will not qualify if you...

  • Clinically significant allergy history
  • Hypersensitivity or intolerance to active or inactive substances in study drugs
  • Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
  • Chronic diseases of kidneys, liver, gastrointestinal tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, immune systems, skin, blood, or eyes
  • Prior gastrointestinal surgeries except appendectomy at least 1 year before screening
  • Conditions affecting drug absorption, distribution, metabolism, or excretion
  • 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 use within 7 days before screening
  • Blood or plasma donation within 3 months before screening
  • Use of hormonal contraceptives within 2 months before screening
  • Use of depot injections within 3 months before screening
  • Pregnancy or lactation, or positive pregnancy test
  • Unprotected sexual intercourse with unsterilized male partner within 30 days before drug administration
  • Participation in another clinical study within 3 months or concurrent
  • Excessive alcohol consumption or substance abuse history
  • Smoking more than 10 cigarettes daily currently or in past 6 months
  • Consumption of alcohol, caffeine, xanthine, citrus fruits, cranberries, rose hips, or St. John's wort within 7 days before dosing
  • Dehydration within 24 hours before dosing
  • Positive tests for HIV, syphilis, hepatitis B or C
  • ECG abnormalities
  • Positive urine test for narcotics or potent medications
  • Positive breath alcohol test
  • Planned hospitalization outside study protocol
  • Inability or unwillingness to comply with study rules
  • Membership in vulnerable populations or conditions compromising consent or study adherence
  • Other investigator-judged factors preventing inclusion or causing withdrawal
  • Withdrawal from study or safety issues during study
  • Missed key study procedures or prohibited drug use
  • Vomiting or diarrhea within 6 hours after dosing
  • Positive pregnancy test during study
  • Other circumstances preventing protocol compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Federal Budgetary Institution of Science "North-West Public Health Research Center"

Saint Petersburg, Russia, 191036

Actively Recruiting

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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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Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers. | DecenTrialz