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

Launched by JOINT STOCK COMPANY "FARMAK" · Nov 15, 2021

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy males and non-pregnant and no breast-feeding females ), ≥18 and ≤55 years of age ) (on the day of Informed Consent). Caucasian race.
• • 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:
• • 1. 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.
• • 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.