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

NCT05123976 | Completed Phase 1

• 1 other identifier: FK/ONZP/2019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bioequivalence; pharmacokinetics; generic drugs; Olanzapine

Outcome Measures

Primary Outcomes (2)

• AUC(0-72h)

  The area under the plasma concentration-time curve from time zero to sampling time 72 hours calculated by linear trapezoidal rule

  up to 72 hours post-administration

• Cmax

  Maximum plasma concentration observed.

  up to 72 hours post-administration

Secondary Outcomes (1)

• tmax.

  up to 72 hours post-administration

Study Arms (2)

Treatment A

EXPERIMENTAL

Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)

Drug: Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)

Treatment B

ACTIVE COMPARATOR

Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)

Drug: Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)

Interventions

Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine) DRUG

After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water .

Also known as: Adagio film-coated tablets 5 mg (JSC Farmak, Ukraine)

Treatment A

Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V) DRUG

After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water .

Also known as: Olanzapine

Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and non-pregnant and no breast-feeding females ), ≥18 and ≤55 years of age ) (on the day of Informed Consent). Caucasian race.
• Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).
• Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive and body weight between 50 kg and 100 kg (on the day of screening).
• Subject was available for the whole study and has provided his/her written informed consent.
• Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and body temperature) and 12-lead ECG. Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Investigator.
• All laboratory screening results within the normal range. Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Clinical Investigator.
• Acceptance of use of contraceptive measures during the whole study by both female and male subjects ).

You may not qualify if:

• Gastrontestinal, renal or hepatic diseases and/or pathological findings present or in history, which might interfere with the drug pharmacokinetics. Any pre-existing disease or condition (e.g. hemicolectomy) for which it can be assumed that absorption, distribution, metabolism and excretion of the IMP will be affected.
• An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug. In any such case subject selection was at the discretion of the Principal Investigator.
• History, presence or known risk of narrow-angle glaucoma.
• Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug's safety, tolerability, bioavailability and/or pharmacokinetics of the IMP.
• Previous liver disease or elevations in serum transaminases ALT or AST ≥ 1.0 ULN at the screening.
• History of kidney disease and with impaired renal function.
• Known hypersensitivity or idiosyncratic reaction to olanzapine or to any of its excipients or any drug or any substance.
• Hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
• Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAII induced urticaria.
• Presence of out-of-range cardiac interval on the ECG at screening or other clinically significant abnormalities, unless deemed non-significant by the Investigator.
• Clinically significant illness within 28 days before the first dosing, including major surgery.
• Any significant clinical abnormality, including a positive result of HBsAg and/or HCV and/or HIV test during screening procedure.
• Positive result of blood pregnancy test at screening or positive urine pregnancy test at check-in or breast-feeding or lack of results of pregnancy test.
• Positive results of drugs in urine at screening and at check-in.
• Positive result of alcohol breath test at screening and at check-in.

Sponsors & Collaborators

• Joint Stock Company "Farmak": lead

Study Sites (1)

QUINTA-ANALYTICA s.r.o.

Prague, 10200, Czechia

Location

MeSH Terms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vlad Udovytskyi

  Joint Stock Company "Farmak"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 17, 2021
• Study Start: October 21, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

CZ (1)