An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover, Oral Bioequivalence Study Comparing of Edaravone Powder For Oral Suspension 105 mg Manufactured by BDR Pharmaceuticals International Pvt Ltd India With Radicut Ors 2.1 % 50 Ml Edaravone Oral Suspension Manufactured for M/S Mitsubishi Tanabe Pharma Corporation Chuo Ku Tokyo Japan In Healthy, Adult Human Subjects Under Fasting Conditions

BDR pharmaceuticals International Pvt Ltd1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2025年7月10日最近更新: 2025年6月28日

研究概览

简要总结

36 number of healthy, adult, human subjects will be recruited to evaluate the bioequivalence of Test product with the Reference product

As per the discretion of the Investigator, a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 36 subjects in period I alone.

Demographic data, medical and medication history, physical examination, 12-lead ECG, haematology, biochemistry, serology, Blood Urea Nitrogen BUN Creatinine Clearance urine routine analysis, additionally for females serum pregnancy test, hormone assay FSH will be done within 21 days and a chest X-ray within 06 months prior to check in

In each period subjects will be housed in the clinical facility for at least 11.00 hours pre dose to 48.00 hours post dose

A washout period of at least 07 days will be maintained between each dosing period

Subjects will be served dinner on the day of check-in for each period. Thereafter, subjects will fast for at least 10.00 hours prior to dosing

Standard meals will be provided at 04.00, 08.00, 12.00, 24.00, 28.00, 32.00 and 36.00 hours post-dose respectively. All meal plans will be identical in all the periods of the study

Blood pressure, radial pulse rate, body temperature, and wellbeing status will be enquired and recorded at pre-dose 00.00 hour (within 75 minutes of before dosing) and at 01.00, 02.00, 04.00, 06.00, 12.00, 24.00 and 36.00 hours (± 60 minutes) post dose

Physical examination and vitals will be recorded before check-in, check out (48.00 hours) for each period and at any time if necessary

Monitoring for adverse events will be done throughout the study period in clinical phase

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: All

入选标准

•Normal healthy adult human male and female subjects of age between 18 to 45 years and BodyMass Index BMI ranges between 18.50 kg per m2 to 29.99 kg per m2 Subjects who have no evidence of underlying disease during screening and check in and whosescreening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits are considered by the physicianor principal or clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to anevaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervoussystem and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinicallaboratory assessments Willing to consume Ovo lacto-vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from the studypersonnel Non smokers Generally healthy, as documented by gynaecological examination and breast examination period Ionly Females of childbearing potential must have a negative serum pregnancy test performed within 21days prior to the initiation of the study and a negative urine pregnancy test prior to check in foreach period If the subject is female currently not pregnant not lactating or not attempting to become pregnantfor 4 weeks before the screening visit throughout the duration of the study and 3 weeks after thesubjects last study related visit for eligible subjects only if applicable has a negative serumpregnancy test and is of non-childbearing potential defined as greater or equal to 01 year post menopausal no menstrual period for at least 12 consecutivemonths without any other medical cause Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy or is of childbearing potential willing to commit to using a consistent and acceptable method of birth controlas defined below for the duration of the study double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film withspermicide intrauterine device IUD with a low failure rate of less than 1 percentage per year or is of childbearing potential and not sexually active willing to commit to using a consistent and acceptablemethod of birth control as defined above for the duration of the study in the event the subjectbecomes sexually active.

排除标准

•Evidence of allergy or known hypersensitivity to Edaravone or its inactive ingredients Subjects with a history of asthma or sulfite induced allergic reactions 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 that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products i.e. coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48:00 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 any unusual diet for whatever reason eg 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 History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine-AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check-in of each period Positive results for alcohol test prior to check-in of each period Any blood donation or excess blood loss within 90 days of check in Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females are likely to become pregnant during the course of the study.