TCTR20210219005尚未招募1 期
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Carvedilol 12.5 mg Tablets and Reference Product (Dilatrend) in Healthy Thai Volunteers under Fasting Conditions
Millimed Co., Ltd. (Branch)0 个研究点目标入组 64 人开始时间: 2021年2月19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
- 64
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 18.0 to 30.0 kg/m2
- •3. 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.
- •4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- •5. 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 check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months
- •prior to check-in 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 check-in 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 check-in in Period 1:
- •Postmenopausal for at least 1 year or
- •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
- •6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
- •7. 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 carvedilol or any component of the product
- •2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes),
- •pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), 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. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- •4. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •5. History or evidence of congestive heart failure, ischaemic heart disease,myocardial infarction or arrhythmia
- •6. History or evidence of diabetes mellitus or hypoglycemia
- •7. History or evidence of chronic obstructive pulmonary disease or asthma
- •8. History or evidence of bradycardia
- •9. Have pulse rate of less than 50 bpm
- •10. History or evidence of shock including cardiogenic shock or hypovolemic shock
研究者
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