TCTR20240514005尚未招募1 期
Bioequivalence study of a randomized, open-label, single dose, fully replicate design of azilsartan 80 mg tablets between reference product (Edarbi) and azilsartan test product in Thai healthy volunteers under fasting condition
Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University0 个研究点目标入组 30 人开始时间: 2024年5月14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
- 20 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1)Healthy Thai male and female subjects based on their medical history and physical examination, aged between 20-45 years, using the age at the time of informed consent
- •based on their birthday given.
- •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, serum potassium and urinalysis.
- •3)Negative hepatitis B test result.
- •4)Not clinically significant findings in vital sign measurement.
- •5)Body weight of at least 45 kg with Body Mass Index (BMI) between 18.5-30.0 kg/m2
- •6)Females participating in this study must adhere to the following criteria:
- •6.1) Females with childbearing potential must meet the following criteria:
- •- Have a negative pregnancy test result and be nonpregnant.
- •- Not be currently breastfeeding.
- •6.2) Female without childbearing potential must fulfill at least one of the following criteria before admission in period 1:
- •- Post menopausal for at least 1 year
- •- Surgical sterilization such as bilateral ligation, bilateral oophorectomy or hysterectomy must have been performed for at least 6 months.
- •7) Demonstrate willingness to comply with all study procedures and adhere to any restrictions outlined in the protocol.
排除标准
- •1)History of allergy to azilsartan or related structures or any component of the product.
- •2)Current or history of alcohol addiction or drug abuse.
- •3)Presence of any evidence or current clinically significant conditions such as asthma, lung disease, seizures, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the studied medication or compromise the safety of the subjects.
- •4)High risk of COVID-19 infection based on a risk assessment questionnaire or positive COVID-19 test.
- •5)History of tobacco or nicotine containing product use within the six months preceding study drug administration.
- •6)Use of injectable contraceptive within 6 months before study drug dministration (for female subjects).
- •7)Use of hormonal contraception, or hormone replacement therapy use within 28 days before study drug administration (for female subjects).
- •8)Use of any medications, including vitamins, minerals (e.g., iron), herbal products (e.g., St. Johns wort), or dietary supplement within 14 days prior to drug administration.
- •9)Consumption of orange, pomelo, grapefruit, or any products containing these fruits within 7 days before study drug administration.
- •10)Consumption of caffeinated beverages and foods, such as tea, coffee, cocoa, cola, chocolate, or energy drinks, within 3 days before study drug administration.
- •11)Testing positive for methamphetamine, cannabinoid, or opiates in a urine drug abuse test.
- •12)Testing positive on alcohol breath test.
- •13)Undergoing surgery or blood donation exceeding 300 mL or experiencing significant blood loss within 90 days prior to study drug administration.
- •14)Participation in other clinical trials within 90 days preceding study drug administration.
- •15)Inability to communicate effectively, including individuals with with language difficulties, poor mental development, psychiatric illness, or impaired cerebral function that may hinder their ability to provide written informed consent or cooperate with the clinical team.
研究者
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