Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05123976
Study type Interventional
Source Joint Stock Company "Farmak"
Contact
Status Completed
Phase Phase 1
Start date October 21, 2020
Completion date November 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT04092725 - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects Phase 1
Completed NCT04459598 - A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants Early Phase 1
Recruiting NCT04181008 - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers Early Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT04406415 - Oral Nafamostat in Healthy Volunteers Phase 1
Completed NCT02534753 - A Pharmacokinetics Study of Intravenous Ascorbic Acid Phase 1
Completed NCT01976078 - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents N/A
Completed NCT01682408 - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability Phase 1
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01214941 - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol Phase 4
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT01260025 - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT00984009 - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice Phase 1
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00983242 - Drug-Drug Interaction Between Colchicine and Verapamil ER Phase 1
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00856570 - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects Phase 1
Completed NCT01276119 - The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males Phase 1
Completed NCT01055964 - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients Phase 3