TCTR20171204002
Not yet recruiting
Phase 4
Comparative Randomized ,Single Dose, Two-Way Crossover, Open-label Study to Determine Bioequivlence of Olanzapine 5 mg Orally Disintegrating Tablets Formulations, Zyprexa Zydis (5 mg) and ZOLAN GPO (5 mg), after Oral Administration to Healthy Thai
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University0 sites30 target enrollmentDecember 4, 2017
ConditionsHealthy volunteers
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Healthy volunteers
- Sponsor
- Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a)Be healthy male or female subjects between 18\-55 years of age (both inclusive).
- •b)Have a Body Mass Index (BMI) between 18\.0\-25\.0 (both inclusive), calculated as weight in kg/height in m2\.
- •c)Have no evidence of underlying disease or clinically significant abnormal finding during screening, medical history examination, physical examination.
- •d)Have no abnormal finding during laboratory examination such as complete blood count, hematocrit, hemoglobin, fasting blood sugar, blood urea nitrogen (BUN), serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, total protein, albumin, HBsAg, Anti\-HCV, Anti\-HIV, urine analysis, chest X\-ray and 12\-Lead ECG recording or judged by physician as clinically insignificant or acceptable.
- •e)Able to understand and comply with the study procedures, in the opinion of the Principal Investigator.
- •f)Able to give voluntary written inform consent for participation in the trial.
- •g)In case of female subjects:
- •â€¢Females of child\-bearing potential agree to use an acceptable method of birth control for entire duration of the study as judge by the investigator(s):
- •i.Non hormonal intrauterine device in place of at least 3 months prior to the start of the study and remaining in place during the study period, or
- •ii.Barrier methods containing or used in conjunction with a spermicidal agent, such as condoms, foams, jellies, diaphragm, etc., or
Exclusion Criteria
- •a)Any history of hypersensitivity to olanzapine or any of its excipients.
- •b)A recent history or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •c)Clinically significant illness within 4 weeks before the start of the study.
- •d)Any history of bronchospasm, asthma, urticaria or other allergic type reactions after taking any medication.
- •e)Any history of suicide attempt and/or present positive result of screening questionnaire for depression and suicidal risk from National Center For Suicide Prevention, Thailand.
- •f)Sitting blood pressure of \< 110/70 mmHg or pulse rate of \< 60 or \> 100 beats per minute. If the blood pressure or pulse rate is not within this range, it can be repeated twice (at intervals of at least 1 minute) to confirm the actual blood pressure or pulse rate based on mean of last two measurements, to minimize any anomaly from recording. If blood pressure is \> 5 mmHg difference between last two measurements, additional (1 or 2\) readings should be obtained, and then the average of these multiple readings is used. The decision regarding enrollment of the subject will be taken by the physician.
- •g)A positive hepatitis screen including HBsAg and/or anti\-HCV.
- •h)A positive test result for anti\-HIV.
- •i)Has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood (1 unit or 350 mL) in the preceding 90 days prior to the start of the study.
- •j)History of difficulty with donating blood or difficulty in accessibility of veins.
Outcomes
Primary Outcomes
Not specified
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