Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.
NCT ID: NCT05123976
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2020-10-21
2020-11-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Treatment A
Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine)
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 .
Treatment B
Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
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 .
Interventions
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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 .
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 .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).
3. 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).
4. Subject was available for the whole study and has provided his/her written informed consent.
5. 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.
6. 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.
7. Acceptance of use of contraceptive measures during the whole study by both female and male subjects ).
Exclusion Criteria
2. 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.
3. History, presence or known risk of narrow-angle glaucoma.
4. 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.
5. Previous liver disease or elevations in serum transaminases ALT or AST ≥ 1.0 ULN at the screening.
6. History of kidney disease and with impaired renal function.
7. Known hypersensitivity or idiosyncratic reaction to olanzapine or to any of its excipients or any drug or any substance.
8. Hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
9. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAII induced urticaria.
10. Presence of out-of-range cardiac interval on the ECG at screening or other clinically significant abnormalities, unless deemed non-significant by the Investigator.
11. Clinically significant illness within 28 days before the first dosing, including major surgery.
12. Any significant clinical abnormality, including a positive result of HBsAg and/or HCV and/or HIV test during screening procedure.
13. 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.
14. Positive results of drugs in urine at screening and at check-in.
15. Positive result of alcohol breath test at screening and at check-in.
16. Positive result of urine cotinine test at screening.
17. Serious mental disease and/or inability to cooperate with clinical team.
18. 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.
19. Body ear temperature is out of the range of 35.7-37.6° C at screening and at check-in.
20. Orthostatic hypotension during the screening procedure.
21. Drug, alcohol (of ≥ 40 g per day pure ethanol), solvents or caffeine abuse.
22. Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 days before the first dosing.
23. Use of any prescription medication for a period of 28 days before the first dosing.
24. Use of any OTC (over-the-counter) medication including vitamins, herbal medications and food supplements less than 14 days before the first dosing.
25. 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.
26. 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.
27. Subjects who have any clinically significant abnormal laboratory safety findings (upon repeat testing, 1 repeat assessment is acceptable) previously or at screening.
1. Anaemia (haemoglobin below 120 g/L for women and 130 g/L for men)
2. Leukopenia (value of WBC below 4.00\*10\_9/L) and/or neutrophilopenia (value of NEU below 2.0 \*10 9/L
3. Thrombocytopenia (value of platelets below 150\*10\_9/L).
28. Less thay 30 days between exit procedure in previous study and the first dosing in this study.
18 Years
55 Years
ALL
Yes
Sponsors
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Joint Stock Company "Farmak"
INDUSTRY
Responsible Party
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Principal Investigators
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Vlad Udovytskyi
Role: STUDY_CHAIR
Joint Stock Company "Farmak"
Locations
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QUINTA-ANALYTICA s.r.o.
Prague, , Czechia
Countries
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Other Identifiers
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FK/ONZP/2019
Identifier Type: -
Identifier Source: org_study_id