CTRI/2025/12/099703尚未招募不适用
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Fully Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Mesalamine Delayed-Release Tablets 1.2g Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division With LIALDA 1.2g Mesalamine Delayed Release Tablets Manufactured for Takeda Pharmaceuticals America Inc Lexington Ma 02421 USA by Cosmo SPA Milan Italy In Healthy Adult Human Subjects Under Fed Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
At least 16 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 16 subjects in period I alone
Equal number of male & female volunteers will be recruited to conducted the study
In each period subjects will be housed in the clinical facility for at least -36.00 hours pre-dose to 72.00 hours post-dose
A washout period of at least 08 days will be maintained between each dosing period
In each period after an overnight fasting of at least 10.00 hours prior to high-fat high-calorie non veg breakfast
In the morning high-fat, high-calorie non veg breakfast will be provided 30 minutes before dosing
After consumption of breakfast a single oral dose of either the test product (T) or reference product (R) will be administered (as per the randomization schedule) with 240mL of water at ambient temperature
Blood pressure, radial pulse rate, body temperature and wellbeing status will be enquired and recorded at -21.00, -17.00 (±60 minutes) and pre-dose 00.00 hour (within 75 minutes of before dosing) and at 03.00, 06.00, 12.00, 24.00, 48.00 and 60.00 hours (±60 minutes) post-dose
Physical examination and vitals will be recorded before check-in, check-out (72.00 hours) for each period and at any time if necessary
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 subjects of age between 18 to 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 consume non vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by the study personnel Non smokers Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject’s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of 1 year post menopausal no menstrual period for at least 12 consecutive months 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 control as defined below for the duration of the study double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide 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 acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active.
排除标准
- •Evidence of allergy or known hypersensitivity to Mesalamine or its inactive ingredients Poor Metabolisers of CYP 2D6 Which is confirmed by carrying out the cytochrome P450 2D6 test 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 ie coffee tea chocolate and 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 an 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 swallowing 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 / excess blood loss within 90 days of check-in Ingestion of any hormonal agent at any time within 14 days prior to start of 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 likely to become pregnant during conduction of the study.
研究者
Dr Pradeep T
Spinos Lifescience and research private limited
研究点 (1)
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