TCTR20220119005尚未招募1 期
Bioequivalence study of an open-label, randomized, two-way crossover design with two-period, two-treatment, two-sequence of test product eletriptan 40 mg film-coated tablets and reference product (RELPAX (TABLETS 40 MG)) in Thai healthy volunteers under fasting condition
Pharmacy Service Center0 个研究点目标入组 32 人开始时间: 2022年1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
- 32
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 45 Years（—）
- 性别
- All
入选标准
- •1) Healthy Thai male and female subjects based on medical history and physical examination, aged between 18-45 years.
- •2) Normal or not clinically significant abnormal of laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count and urinalysis.
- •3) Negative hepatitis B test result.
- •4) Not clinically significant findings in vital sign measurement.
- •5) Body weight has to be at least 45 kg with Body Mass Index (BMI) between 18.5-25.0 kg/m2
- •6) Females who participate in this study must:
- •6.1) be nonpregnant (negative result for pregnancy test).
- •6.2) be not currently breastfeeding.
- •6.3) Abstain from either hormonal contraceptive method (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone releasing IUDs, postcoital contraception) and hormone replacement therapy for at least 28 days before admission in period 1. Injectable contraceptives will be discontinued at least 6 months before admission in period 1. Female subjects without childbearing potential must meet at least one of the following criteria before admission in period 1
- •- Post menopausal for at least 1 year or
- •- Surgically sterile (bilateral ligation, bilateral oophorectomy or hysterectomy) at least 6 months
- •6.4) Use acceptable non-hormonal contraceptive method if having childbearing potential for at least 2 weeks before admission in period 1 until 7 days after the end of study in period 2 judged by the clinical investigators, such as condoms, non-hormonal IUD, or willing to remain abstinence (not engage in sexual intercourse)
- •7) Subjects are willing to comply with study procedures and restrictions.
排除标准
- •1)Subjects with a history of allergy to eletriptan or related structures or any component of the product.
- •2)Subjects with currently or history of alcohol addiction or drug abuse.
- •3)Subjects with currently or evidence of clinically significant of asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, arrhythmia, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the medication studied or safety of the subjects.
- •4)Subjects with a history of tobacco or nicotine containing product use within six months before admission in period 1 and cannot abstain during the study.
- •5)Subjects who use any medications including vitamins or mineral (e.g., iron), herbal products (e.g., St. Johns wort), and dietary supplement, within 14 days before admission in period 1 and cannot discontinue them during the study
- •6)Subjects who had consumed orange or pomelo or grapefruit or its supplement/containing products within 7 days before admission in period 1 and cannot stop consuming them during the study
- •7)Subjects who had consumed caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before admission in period 1 and cannot stop consuming them during the study.
- •8)Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates).
- •9)Subjects with positive alcohol breath test.
- •10)Subjects with a history of surgery or blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study.
- •11)Subjects who participate in other clinical trials within 90 days before the initiation of this study.
- •12)Subjects who inability to communicate well (i.e., language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team
研究者
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