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Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.

NCT05123976 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-11-17

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics

Interventions

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 .

Sponsors & Collaborators

  • Joint Stock Company "Farmak"

    lead INDUSTRY

Principal Investigators

  • Vlad Udovytskyi · Joint Stock Company "Farmak"

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123976 on ClinicalTrials.gov