IRCT20130313012810N32已完成Unknown
Bioequivalence study of Vigabatrin 500 mg film coated tablet manufactured by Modava Pharmaceutical Company
Modava Pharmaceutical Company0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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 50 years（—）
- 性别
- All
入选标准
- •The weight range of participating candidates should be between 60-100 kg.
- •Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose.
- •Volunteers who have agreed to an informed consent form.
- •All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw.
排除标准
- •History of allergic or adverse reaction to Vigabatrin or any similar product.
- •Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
- •Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s).
研究者
相似试验
已完成
1 期
Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral AdministrationTherapeutic EquivalencyNCT04468282Orphelia Pharma20
尚未招募
不适用
Safety and efficacy of vigabatrin add on compared to placebo in Lennox-Gastaut Syndrome: A randomizedcontrolled trialCTRI/2022/12/048517Dr Jayantee Kalita Principal Investigator
暂停
1 期
Bioequivalence Study of 50 mg Dolutegravir Film-coated Tablets in Healthy Thai VolunteersBioequivalence Study of 50 mg Dolutegravir Film-caoted Tablets in Healthy Thai VolunteersTCTR20220907001nison Laboratories Co., Ltd.30
尚未招募
1 期
Bioequivalence study of sitagliptin 100 mg film-coated tablet in Thai healthy volunteersThai healthy male and female subjects , Aged 18 to 50 years , BMI were within 18-25 kg/m2 , Good health confirming by physical and clinical.HealthyTCTR20210824012Faculty of Medicine, Chulalongkorn University26
尚未招募
1 期
Bioequivalence study of empagliflozin 25 mg film-coated tablet in Thai healthy volunteersHealthy Thai VolunteersTCTR20230719003Macrophar Co., Ltd.28