An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Fully Replicate Reference scaled Average Oral Bioequivalence Study Comparing Mesalazine Gastro Resistant Tablets BP 500 mg Manufactured by Sunglow Lifescience Pvt Ltd with Salofalk 500 mg Mesalazine Gastro Resistant Tablets Marketing Authorization Holder Dr Falk Pharma GmbH Leinenweberstr 5 79108 Freiburg Germany In Healthy Adult Human Subjects Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Mesalazine Gastro Resistant Tablets BP 500 mg Manufactured by Sunglow Lifescience Pvt Ltd with Salofalk 500 mg Mesalazine Gastro Resistant Tablets Marketing Authorization Holder Dr Falk Pharma GmbH Leinenweberstr 5 79108 Freiburg Germany In Healthy Adult Human Subjects Under Fasting Conditions
研究概览
简要总结
60 number of healthy, adult, human subjects will berecruited to evaluate the Bioequivalence of Test product with the Referenceproduct.
The study will be conducted in Two stage.
STAGE 01:
At least 48 number of healthy, adult, human subjects will berecruited to evaluate the Bioequivalence of Test product with the Referenceproduct.
As per the discretion of the Investigator, a sufficientnumber of stand-by subjects will be included additionally to ensure successfuldosing of 48 subjects in period I alone.
STAGE 02:
At least 12 number of healthy, adult, human subjects will berecruited to evaluate the Bioequivalence of Test product with the Referenceproduct.
As per the discretion of the Investigator, a sufficientnumber of stand-by subjects will be included additionally to ensure successfuldosing of 12 subjects in period I alone.
Note:
Stage 02 will be conducted with 12 subjects in case ofrequirement and the report will be prepared for 48 Subjects if stage 02 is notconducted.
In each period subjects will be housed in the clinicalfacility for at least -36.00 hours pre dose to 48.00 hours post dose
A washout period of at least 08 days will be maintainedbetween each dosing period
In each period, after an overnight fasting of at least 08.00hours, in the morning a single oral dose of either the test product (T) orreference product (R) will be administered (as per the randomization schedule)with 240 mL of drinking water at ambient temperature
Blood pressure, radial pulse rate, body temperature andwellbeing status will be enquired and recorded at pre-dose -21.00, -17.00 and00.00 hour (within 75 minutes of before dosing) and at 03.00, 06.00, 12.00 and24.00 hours (±60 minutes) post-dose
Monitoring for adverse events will be done throughout thestudy period in clinical phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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 Body Mass Index BMI ranges between 18.50 kg per m2 to 30 00 kg per 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 are considered by the physician or principal or clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume ovo Lacto vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers Generally healthy, as documented by gynaecological examination and breast examination period I only Females of child bearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check in for each period If the 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 subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non-childbearing potential defined as greater or equal to 01 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 Mesalazine or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuseexisting Exclude 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 that might compromise the haemopoeitic gastrointestinal renal hepaticcardiovascularMusculoskeletal respiratory central nervous system or any other body systemincluding presence of DiabetesMellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and /or xanthine containing products ie coffee tea chocolate caffeinecontaining sodas colasetc cigarettes and tobacco containing products for at least 48.00 hours priorto check in and throughout the entirestudy Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within48.00 hoursprior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check-in andthroughout thestudy and any over the counter medicinal products herbal medications within 07 daysprior to study check in andthroughout the study Subjects who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior todosing andthroughout 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 barbituratesBAR cocaine COCbenzodiazepines 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 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.
结局指标
主要结局
To assess the Bioequivalence on Mesalazine Gastro Resistant Tablets BP 500 mg Manufactured by Sunglow Lifescience Pvt Ltd with Salofalk 500 mg Mesalazine Gastro Resistant Tablets Marketing Authorization Holder Dr Falk Pharma GmbH Leinenweberstr 5 79108 Freiburg Germany In Healthy Adult Human Subjects Under Fasting Conditions
时间窗: 24 Time points | 00 00 hrs 03 00 hrs 04 00 hrs 05 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 09 00 hrs 10 00 hrs 10 50 hrs 11 00 hrs 11 50 hrs 12 00 hrs 12 50 hrs 13 00 hrs 13 50 hrs 14 00 hrs 15 00 hrs 16 00 hrs 18 00 hrs 20 00 hrs 24 00 hrs 36 00 hrs and 48 00 hrs
次要结局
- To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human subjects under fasting conditions(24 Time points)