Trials / Recruiting
RecruitingNCT07421011
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
A Randomized, Open-label, Crossover Study to Assess the Comparative Pharmacokinetics, Bioequivalence, and Safety of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Valenta Pharm JSC · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trimedat® | A single dose of R or T drug in each of 2 periods of the study under fasted conditions |
Timeline
- Start date
- 2025-11-06
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2026-02-19
- Last updated
- 2026-02-19
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT07421011. Inclusion in this directory is not an endorsement.