Trials / Completed
CompletedNCT05123976
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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Joint Stock Company "Farmak" · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
A comparative, open-label, randomized, two-period, two-treatment, two-sequence, two-way crossover clinical trial to evaluate the bioequivalence of single doses of test product Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine) and reference product Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V) in healthy, adult male and female subjects under fasted conditions. During each period 22 blood samples were taken in each Study Period: prior to dosing (-1.0) and 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 14.0, 16.0, 24.0, 48.0 and 72.0 hours after IMP administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine) | After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water . |
| DRUG | Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V) | After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water . |
Timeline
- Start date
- 2020-10-21
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
- First posted
- 2021-11-17
- Last updated
- 2021-11-17
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT05123976. Inclusion in this directory is not an endorsement.