PharmacokineticsPhase 1NCT05123976

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

A Phase 1 study testing Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine) and Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V) in people with Pharmacokinetics, run by Joint Stock Company "Farmak" at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine) and Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCzechia
Study dates: 21 Oct 2020to 30 Nov 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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 ).

Who cannot join

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.

Show all 31Show fewer

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.
Positive result of urine cotinine test at screening.
Serious mental disease and/or inability to cooperate with clinical team.
Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic BP and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
Body ear temperature is out of the range of 35.7-37.6° C at screening and at check-in.
Orthostatic hypotension during the screening procedure.
Drug, alcohol (of ≥ 40 g per day pure ethanol), solvents or caffeine abuse.
Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 days before the first dosing.
Use of any prescription medication for a period of 28 days before the first dosing.
Use of any OTC (over-the-counter) medication including vitamins, herbal medications and food supplements less than 14 days before the first dosing.
Getting a tattoo, body piercing or any cosmetic treatment involving skin piercing within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study.
Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
Subjects who have any clinically significant abnormal laboratory safety findings (upon repeat testing, 1 repeat assessment is acceptable) previously or at screening.
Anaemia (haemoglobin below 120 g/L for women and 130 g/L for men)
Leukopenia (value of WBC below 4.00*10_9/L) and/or neutrophilopenia (value of NEU below 2.0 *10 9/L
Thrombocytopenia (value of platelets below 150*10_9/L).
Less thay 30 days between exit procedure in previous study and the first dosing in this study.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

QUINTA-ANALYTICA s.r.o.
Prague, 10200

Other trials in Czechia

About this study

Official title: 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.

Read the 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: Pharmacokinetics
Being tested: Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine), Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
Keywords: bioequivalence, pharmacokinetics, generic drugs, Olanzapine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)Drug
Also called Adagio 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 .
Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)Drug
Also called Olanzapine
After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water .

Study groups in NCT05123976
Study group	Role	What they receive
Treatment A	Experimental	Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine) Receives: Drug: Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)
Treatment B	Active comparator	Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V) Receives: Drug: Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC(0-72h)
The area under the plasma concentration-time curve from time zero to sampling time 72 hours calculated by linear trapezoidal rule
Measured: up to 72 hours post-administration
Cmax
Maximum plasma concentration observed.
Measured: up to 72 hours post-administration

Secondary outcomes (1)

tmax.
The time of the maximum plasma drug concentration
Measured: up to 72 hours post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202030 Nov 2020

First posted17 Nov 2021
Study start21 Oct 2020
Primary completion30 Nov 2020
Study completion30 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05123976
Sponsor's protocol ID: FK/ONZP/2019
Status last verified: Nov 2021
First submitted: 15 Nov 2021
Last updated: 17 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT05123976
Acronym / sponsor ID: FK/ONZP/2019
Conditions: Pharmacokinetics
Keywords: bioequivalence, pharmacokinetics, generic drugs, Olanzapine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Joint Stock Company "Farmak"Industry (pharma, biotech, devices)
Study start: 21 Oct 2020 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 30 Nov 2020 (actual)
First posted: 17 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment A	Experimental	Drug: Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)
Treatment B	Active comparator	Drug: Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (31 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)Also: Adagio 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	Treatment A
Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)Also: OlanzapineAfter an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water .	Drug	Treatment B

Primary outcome

AUC(0-72h)
Time frame: up to 72 hours post-administration
The area under the plasma concentration-time curve from time zero to sampling time 72 hours calculated by linear trapezoidal rule
Cmax
Time frame: up to 72 hours post-administration
Maximum plasma concentration observed.

1 secondary outcome

tmax.
Time frame: up to 72 hours post-administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.

Related trials for Pharmacokinetics

RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vlad Udovytskyi study chair

Joint Stock Company "Farmak"

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-72h) (time frame: up to 72 hours post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05123976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.