TCTR20180103001尚未招募1 期
Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Olanzapine 5 mg Orodispersible Tablets (5 MG TABLET)) and Reference Product (Zyprexa® Zydis®) in Healthy Thai Volunteers under Fasting Conditions
International Bio Service0 个研究点目标入组 30 人开始时间: 2018年1月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy Thai male/female subjects between the ages of 18 to 55 years
- •2. Non-smoker and/or non-consumer of nicotine containing products
- •3. Body mass index between 18.0 to 25.0 kg/m2
- •4. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening
- •Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- •5. Non-pregnant woman (negative pregnancy test) and not currently breast feeding
- •6. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1:
- •- Postmenopausal for at least 1 year or
- •- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
- •7. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study.
- •8. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
排除标准
- •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, diabetes mellitus, hyperglycemia, gastrointestinal, hematological, endocrine (e.g. thyroid), pulmonary or respiratory (e.g. allergic rhinitis, asthma), cardiovascular (e.g. arrhythmia or hypotension), psychiatric disorder (e.g. depression), neurologic (e.g. CNS disorder, seizures or Parkinson’ disease), cerebrovascular, narrow-angle glaucoma or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing or chronic urticarial) or any significant ongoing chronic medical illness
- •3. History of sensitivity to heparin or heparin-induced thrombocytopenia
- •4. Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- •5. History of preceding diarrhea or vomiting within 24 hours prior to admission in each period
- •6. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
- •7. Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day or 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.
- •8. Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per min on screening day or on the day of admission. If abnormal pulse rate 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.
- •9. 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility.
- •10. Investigation with blood sample shows positive test for HBsAg.
- •11. Investigation with blood sample shows level of potassium less than 3.4 or more than 4.5 mmol/L at screening laboratory test.
- •12. Investigation with blood sample shows level of magnesium less than 1.6 or more than 2.4 mg/dL at screening laboratory test.
- •13. Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- •14. History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •15. History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •16. Consumption or drinking of grapefruit juice or orange or its supplement/ containing products and cannot abstain f
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