TCTR20190227001已完成4 期
Bioequivalence Study of 8 mg Galantamine HBr Prolonged Release Capsules under Fasting and Fed Conditions in Healthy Volunteers
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University0 个研究点目标入组 26 人开始时间: 2019年2月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
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
- 15 Years 至 18 Years（—）
- 性别
- All
入选标准
- •1) Male and female subjects age between 18-45 years
- •2) Body Mass Index (BMI) between 18.5-25.0 kg/m2 and body weight not less than 45 kg
- •3) Healthy subjects based on medical history and physical examination
- •4) Normal or not clinically significant abnormal of clinical laboratory results including blood urea nitrogen (BUN), serum creatinine, AST, ALT, total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count and urinalysis
- •5) Clinical laboratory result of hepatitis B is negative.
- •6) No clinically significant findings in vital sign measurement and an electrocardiogram (EKG)
- •7) Non smoker or stop smoking for at least 6 months
- •8) Females who participate in this study are:
- •8.1) Non pregnant female (negative result for pregnancy test)
- •8.2) Unable to have children (e.g. tubal ligation, hysterectomy, being postmenopausal at least 1 year before the enrollment) or
- •8.3) With childbearing potential, whom must commit to using acceptable non-hormonal contraceptive method of birth control for at least 2 weeks before and during the study as judged by the clinical investigators, such as condoms, non hormonal intrauterine device (IUD), or willing to remain abstinence (not engage in sexual intercourse) or
- •8.4) Not currently breast feeding
- •9) Subjects are able, willing, and likely to comply with study procedures and restrictions.
排除标准
- •1) Subjects with a history of allergy to galantamine or related structure of galantamine or other components in the formulation
- •2) Subjects with currently or history of alcohol addiction or drug abuse
- •3) Subjects with currently or history of severe asthma, lung disease, seizures, stomach bleeding or ulcer, heart rhythm problem, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the medication or safety of the subjects
- •4) Subjects who use of any medication (especially the drug which inhibited CYP2D6 and CYP3A4), including vitamins, herbal products, and dietary supplement, within 14 days before and during the study
- •5) Subjects who are unable to refrain from consumption of orange, pamelo, grapefruit within 7 days before and during the study
- •6) Subjects who are unable to refrain from caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before and during the study
- •7) Subjects with a history of blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study
- •8) Subjects who participate in other clinical trials within 90 days before the initiation of the study
- •9) Subjects who are vulnerable to hypotension or volume depletion as considered by the clinical investigators
- •10) Subjects with systolic blood pressure less than 90 mmHg and diastolic blood pressure less than 60 mmHg
- •11) Subjects with pulse rate less than 50 beat/minute or more than 100 beat/minute
- •12) Female subjects with a history of hypermenorrhea
研究者
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