TCTR20190316002尚未招募1 期
An Open Label, Randomized, Two-treatment, Two-period, Twosequence, Multiple Oral Dose, Crossover Bioequivalence Study of Generic Trimetazidine Dihydrochloride 35 mg Modified Release Film Coated Tablets and Reference Product (VASTAREL (R) MR) in Healt
International Bio Service Co. Ltd.0 个研究点目标入组 28 人开始时间: 2019年3月16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
- 28
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 or female subjects between the ages of 18 to 55 years.
- •2 Body mass index between 18.5 to 30.0 kg/m2.
- •3 Non-smoker and/or non-consumer of nicotine containing products
- •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 in
- •Period 2. Female subjects of non-childbearing potential must meet at least one of
- •the following criteria prior to admission in Period 1:
- •ï‚· Postmenopausal for at least 1 year or
- •ï‚· 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 in Period 2.
- •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 trimetazidine or any of the excipients
- •2 History or evidence of clinically significant renal, hepatic, gastrointestinal,
- •hematological (e.g. anemia), endocrine (e.g. thyroid), pulmonary or respiratory (e.g.
- •asthma), cardiovascular, psychiatric, neurologic (e.g. convulsion), allergic disease
- •(including drug allergies, but excluding untreated, asymptomatic, seasonal allergies
- •at time of dosing) or any significant ongoing chronic medical illness
- •3 History or evidence of angina attacks, unstable angina pectoris or myocardial
- •4 History or evidence of Parkinson disease, parkinsonian symptoms (e.g. tremor,
- •akinesia, hypertonia), restless leg syndrome or other related movement disorders
- •5 History of 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. gastrectomy, enterectomy,
- •gastritis or duodenal or gastric ulceration other than appendectomy
- •8 History of preceding 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 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 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.
- •11 Investigation with blood sample shows positive test for HBsAg.
- •12 Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for
- •ALT, AST or bilirubin levels at screening laboratory test
- •13 Have renal creatinine clearance (Clcr) < 30 mL/min based on serum creatinine
- •results at the screening laboratory test
- •Calculation for Creatinine Clearance*
- •Clcr (mL/min) =
- •14 History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e.,
- •alcohol consumption of more than 14 standard drinks per week for men and 7 standard
- •drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL
- •of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.)
- •15 History or evidence of alcohol consumption or alcohol-containing products and
- •cannot abstain for at least 48 hours prior to admission and continued for entire
- •duration of the study or alcohol breath test shows positive result
- •In case of alcohol breath test result represents the alcohol concentration range of
- •1 - 10 mg% BAC and the physician carefully considers that the value came from
- •other reasons, not from the alcohol drinking behavior of subjects, the test will be
- •repeated two times separately, not more than 10 minutes. The result of the last time
- •should be used for subject’s eligibility which must be 0 mg%BAC.
- •16 History or evidence of consumption of tea, coffee, caffeine- or xanthine-containing
- •products (i.e. chocolates or cola drinks) and cannot abstain for at least 48 hours prior
- •to admission and continued for entire duration of the study
- •17 Consume or drink juice of grapefruit or orange or pomelo or its
- •supplement/containing products and cannot abstai
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