Bradycardia Hypotension Blurred vision Cold Clammy Pale skin Depression Dizziness Fainting Fatigue General feeling of weakness Palpitations Rapid or shallow breathing Thirst Vomiting Di Olanzapine Antipsychotics Compare bioavailability study
Conditions
Interventions
This comparative bioavailability study is conducted to compare the extent and the rate to which a substance or its active moiety is delivered from a pharmaceutical form and becomes available in the ge
Olanzapine 5 mg,Zyprexa Zydis
Sponsors
International Bio Service Co., Ltd.
International Bio Service Co.,
Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Male and female, healthy volunteers aged 18-55 years, body mass index between 18.0 to 30.0 kg/sq.m. All of them should be able to complete the clinical study including the follow-up and capable of providing written informed consent.
Exclusion criteria
Exclusion criteria: 1.History of allergic reaction or hypersensitivity to olanzapine or any of the component of the formulation. 2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric, neurologic, allergic disease or any significant ongoing chronic medical illness. 3.History or evidence of glucoma. 4.History or evidence of a genetic disease, phynylketouria. 5.History or problems with swallowing tablet or capsule. 6.History of sensitivity to heparin or heparin-induced thrombocytopenia. 7.Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulcerartion other than appendectomy. 8.History of preceding vomiting or diarrhea within 24 hours prior to admission in each period. 9.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine). 10.Has sitting systolic blood pressure less than 90 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mmHg or more than 89 mmHg at screening or on the day of admission. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject's eligibility. 11.Has pulse rate less than 60 beats per min or more than 100 beats per min at screening or on the day of admission. If abnormal pulse rate detects, the measurement should be reported two more times after take a rest at least 5 minutes each. The last measurement value should be used to determine the subject's eligibility. 12.12-lead ECG demonstrating QTc more than 450 msec, a QRS interval more than 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility. 13.Investigation will blood sample shows positive test for HBsAg at screening. 14.Investigation will blood sample shows low neutrophil counts which less than 40% or more than 70.3% for male or less than 40% or more than 73.1% for female at screening. 15.Abnormal liver function, more than and equal 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening. 16.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing product and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period. 17.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain at least 7 days prior to admission and continued until last sample collection in each study period. 18.Consumer or drink juice of grapefruit or orange or pomelo or its supplement or containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period. 19.Use of prescription or nonprescription drugs e.g.paracetamol, erythomycin, ketoconazole, herbal medications or supplements e.g. St.John's wort, vitamins or mine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine and compare the rate and extent of absorption of a test and reference formulations 0.50 - 72 hours; Tmax range (2.00-10.00 hours), Half-life (approximately 29-38 hours), Cmax and Truncated AUC0-72 for Olanzapine,To determine and compare the rate and extent of absorption of a test and reference formulations No later than 7 months after receiving the certificate of approval from the Ethics Committees. Cmax and Truncated AUC0-72 for Olanzapine | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety of test and reference formulations Nearly planned blood collection time. Asking the all subjects to response for AE | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed