An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Fully Replicate Reference scaled Average Oral Bioequivalence Study Comparing Diclofenac Sodium Sustained Release Tablet 100 mg manufactured by Unique Pharmaceutical Laboratories A Division of J B Chemicals & Pharmaceuticals Ltd Plot No 218 219 GIDC Industrial Area Panoli 394 116 Gujarat with VOLTAREN SR Diclofenac Sodium Film Coated Tablet 100 mg manufactured by Novartis Farma SPA Torre Annunziata 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
- 36
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Diclofenac Sodium Sustained Release Tablets 100 mg manufactured by Unique Pharmaceutical Laboratories A Division of J B Chemicals & Pharmaceuticals Ltd Plot No 218 219 GIDC Industrial Area Panoli 394 116 Gujarat with VOLTAREN SR 100 mg Diclofenac Sodium film coated tablet manufactured by Novartis Farma SPA Torre Annunziata Italy In Healthy Adult Human Subjects Under Fed Conditions
研究概览
简要总结
At least 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
Note If needed the study may be conducted as batch wise
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 with a washout period of at least 07 days from the successive dosing day
In each period after an overnight fasting of at least 08.00 hours 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 or reference product will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature
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 and 24.00 hours (±60 minutes) post dose
ECG will be recorded before check out 48.00 hours for each period and if any subject is withdrawn or dropped out during the study
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 Diclofenac 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 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.
结局指标
主要结局
To assess the Bioequivalence on Diclofenac Sodium Sustained Release Tablets 100 mg manufactured by Unique Pharmaceutical Laboratories A Division of J B Chemicals & Pharmaceuticals Ltd Plot No 218 219 GIDC Industrial Area Panoli 394 116 Gujarat with VOLTAREN SR 100 mg Diclofenac Sodium film coated tablet manufactured by Novartis Farma SPA Torre Annunziata Italy In Healthy Adult Human Subjects Under Fed Conditions
时间窗: 23 Time Points | 00 00 hrs 00 50 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 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 fed conditions(23 Time Points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited