TCTR20221027004Unknown1 期
Bioequivalence Study of A Randomized, Open-Label, Single Dose, Two-Way Crossover Design of Celecoxib 200 mg Capsule Formulations between Celebrex and Celecoxib 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 48 人开始时间: 2022年10月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
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)Male and female subjects age between 18-45 years (using the age at last birthday on the date of informed consent).
- •2)Body Mass Index (BMI) between 18.5-25.0 kg/m2 (after decimal rounding) 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 (SCr), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, serum potassium, complete blood count, and urinalysis.
- •5)Clinical laboratory result of hepatitis B is negative.
- •6)No clinically significant findings in vital sign measurement.
- •7)Females who participate in this study are:
- •7.1) be nonpregnant female (negative result for pregnancy test)
- •7.2) be not currently breastfeeding
- •7.3) 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.
- •7.4) For childbearing potential: commit to use acceptable non-hormonal contraceptive method of birth control for at least 2 weeks before and during the study judged by the clinical investigators, such as condoms, non-hormonal IUD, or willing to remain abstinence (not engage in sexual intercourse)
- •7.5) Female subjects of non-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
- •8)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 celecoxib or related structure of celecoxib or other components in the formulation
- •2)Subjects who demonstrated allergic-type reaction of sulfonamides and NSAIDs
- •3)Subjects with currently or history of alcohol addiction or drug abuse
- •4)Subjects with currently or history of asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, hepatic disease, renal disease, endocrine disease, cardiovascular disease or any other conditions that may affect bioavailability of the medication or safety of the subjects
- •5)Subject who has hyperkalemia.
- •6)Subjects who have high risk for COVID-19 infection based on risk assessment questionnaire or who are positive for COVID-19 test.
- •7)Subjects who has history of use of tobacco or nicotine containing products within six months before admission in period 1 and cannot abstain during the study
- •8) Subjects who use of any medication (especially the drug which inhibited CYP2C9), including vitamins, herbal products, and dietary supplement, within 14 days before admission in period 1 and cannot abstain during the study
- •9)Subjects who are unable to refrain from consumption of orange, pomelo and grapefruit within 7 days before admission in period 1 and cannot abstain during the study
- •10)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 admission in period 1 and cannot abstain during the study.
- •11)Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates)
- •12)Subjects with positive alcohol breath test
- •13)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
- •14)Subjects who participate in other clinical trials within 90 days before the initiation of the study
研究者
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