Phase 1Completed
Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.
A Comparative, Open-label, Randomized, Two-period Bioequivalence Study of Olanzapine Film-coated Tablets 5 mg (JSC Farmak, Ukraine) vs Zyprexa® Coated Tablets 5 mg (Eli Lilly, Nederland B V) in Healthy Subjects Under Fasted Conditions.
- Sponsor
- Joint Stock Company "Farmak" (Industry)
- Enrolment
- 32 enrolled
- Conditions
- Pharmacokinetics
- Interventions
- Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine); Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
- Ages
- adults
- Registry
- NCT05123976
Full record on ClinicalTrials.gov
From the registry
This study was designed to assess the bioequivalence of Olanzapine tablets of two different manufacturers and to investigate the safety and tolerability of Olanzapine tablets of two different manufacturers.
Primary outcomes
- AUC(0-72h)
- Cmax
History
Registered
Primary completion
Started