CTRI/2024/07/071462尚未招募Unknown
An Open Label Balanced Randomized Single Dose One Treatment Fasting Vs Fed Two Sequence Fasting And Fed Two Period Two Way Crossover Oral Pharmacokinetics Study Comparing Mexiletine Hydrochloride Capsule 200 Mg Manufactured By Celogen Generics Pvt Ltd On Behalf Of Dawa Limited In Healthy Adult Human Male Subjects Under Fasting and Fed Conditions - Nil
DAWA Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Extensive metabolisers as proven by testing cytochrome P450-2D6 will be included
- •Normal healthy adult human male subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2
- •Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in
- •Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
- •Healthy as documented by the medical history physical examination (including but may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system) and vital sign assessments
- •Generally healthy as documented by 12 lead electrocardiogram (ECG) Chest X-Ray and clinical laboratory assessments
- •Willing to ovo lacto vegetarian diet and non vegetarian diet
- •Non smokers or ex smokers Ex smokers are defined as someone who has completely stopped smoking for at least the past 03 months
- •Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
排除标准
- •Poor Metabolisers of CYP 2D6 (Which is confirmed by carrying out the cytochrome P450-2D6 test)
- •Evidence of allergy or known hypersensitivity to Mexiletine Hydrochloride or its inactive ingredients
- •Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
- •Any major illness in the last three months or any significant ongoing chronic medical illness
- •Renal or liver impairment
- •Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
- •History of alcohol addiction or abuse
- •Consumption of caffeine and or Xanthine containing products
- •containing sodas colas etc cigarettes and tobacco containing products for at least 24.00 hours prior to check in and throughout the entire study
- •Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study
- •Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study
- •Subjects who have taken an unusual diet for whatever reason (e.g. low salt) for 48.00 hours prior to dosing and throughout the study
- •Subject who had participated in any other study within the 90 days of check in
研究者
相似试验
已完成
Unknown
To study the safety of capsaicin tablets in healthy adult humansCTRI/2023/03/050250Dr Shefali Thanawala
尚未招募
Unknown
To study the comparative bioavailability of Guanfacine suspension in healthy adult volunteersCTRI/2024/07/071015Brillian Pharma Inc
尚未招募
Unknown
To assess the bioavailability of Guanfacine suspension 4 mgCTRI/2024/07/071202Sciecure Pharma Inc
招募中
Unknown
To evaluate the bioequivalence of Relugolix 120 mg tabletsCTRI/2024/07/070477BDR Pharmaceuticals Internationals Pvt Ltd
尚未招募
Unknown
An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Crossover Oral Bioavailability Study Of Vitamin C Sustained Release Sr Tablets 500 MgCTRI/2024/08/071926utriventia Limited