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Comparative, Single-Dose, 2-Way Cross-Over Bioavailability Study of Two Olanzapine 10 Mg Tablet Formulations in
Emilija Atanasovska1, Krume Jakjovski1, Kristina Pavlovska1
1Department of Preclinical and Clinical Pharmacology & Toxicology, Faculty of Medicine, University "Ss. Cyril and Methodius", 50 Divizija 6, 1000 Skopje, Republic of North Macedonia.
A new generic Olanzapine tablet formulation was found to be bioequivalent to the reference drug. This study confirms the generic Olanzapine is well-tolerated and a viable alternative for patients.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Development
Background:
- Olanzapine is an atypical antipsychotic used for schizophrenia and bipolar disorder.
- Regulatory agencies like the EMA require bioequivalence studies for generic drug approval.
Purpose of the Study:
- To compare the pharmacokinetics of two 10 mg Olanzapine tablet formulations.
- To assess bioequivalence between a generic and reference Olanzapine product.
Main Methods:
- A randomized, open-label, single-dose, cross-over study in 24 healthy volunteers.
- Pharmacokinetic parameters (Cmax, AUC) were measured over 144 hours post-administration.
- Bioequivalence was determined based on EMA guidelines (90% CI within 80-125%).
Main Results:
- All 24 subjects completed the study.
- The 90% confidence intervals for key pharmacokinetic parameters were within the bioequivalence range.
- The generic Olanzapine demonstrated bioequivalence to the reference formulation.
Conclusions:
- The generic Olanzapine 10 mg tablet is bioequivalent to the reference product.
- The generic formulation was well-tolerated in healthy volunteers.
- This generic Olanzapine offers an acceptable alternative for treatment.
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