At a glance
ClinicalIndex Comparison Record- ✓Healthy male and female subjects aged 18 to 45 years
- ✓Body mass index between 18.5 and 27 kg/m²
- ✓Verified healthy status by standard clinical, laboratory and instrumental examination
- ✓Females must have negative pregnancy test
- ✕History of serious allergic problems or allergic reactions to memantine or product components
- ✕Any acute or chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, gastrointestinal, liver, kidney, or blood systems
- ✕Acute infectious disease within 4 weeks prior to study start
- ✕Medication use within 4 weeks prior to study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg Tablets Versus Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg Tablets in Normal Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Memantinol tablets, 20 mg and Akatinol Memantine® tablets, 20 mg for Bioequivalence, AUC, Cmax, Pharmacokinetics. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects
Study Details
Timeline
Interventions
Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition
Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition