An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Valsartan/Hydrochlorothiazide Tablets USP 320 mg/25 mg Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division with Diovan HCT Valsartan/Hydrochlorothiazide Tablets USP 320 mg/25 mg Distributed by Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 In Healthy Adult Human Subjects Under Fasting 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
- 主要终点
- To assess the Bioequivalence on Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division Dhamrai Dhaka Bangladesh with Diovan HCT Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Distributed by Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936
研究概览
简要总结
An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Two-Way Crossover, Oral Bioequivalence Design In Healthy, Adult Human Subjects Under Fasting Conditions
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
In each period subjects will be housed in the clinical facility for at least 11 00 hrs pre dose to 24 00
hrs post dose
A washout period of at least 07 days will be maintained between each dosing period
After an overnight fasting of at least 10 00 hours, in the morning a single oral dose of either the test
product T or reference 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 and wellbeing status will be enquired and
recorded at pre dose 00 00 hr within 75 minutes of before dosing and at 01.00 02.00 04.00 06.00 08.00 and 12.00 plus or minus 60 minutes post dose
Physical examination and vitals will be recorded before check in check out 24 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 subjects of age between 18 45 years and Body Mass Index BMI ranges between 18 50 kg m2 to 29 99 kg m2 according to the formula of BMI weight kg height 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 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 instruction from 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 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 subject s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non childbearing potential defined as 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 1 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 Valsartan and hydrochlorothiazide 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 ie 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 meals 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 checkin 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 this study period Positive results for alcohol test prior to check in of each period Any blood donation excess blood loss within 90 days of checkin Ingestion of any hormonal agent at any time within 14 days prior to the start of the study checkin 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 who are are likely to become pregnant during the course of the study.
结局指标
主要结局
To assess the Bioequivalence on Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division Dhamrai Dhaka Bangladesh with Diovan HCT Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Distributed by Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936
时间窗: 21 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 08 00 hrs 10 00hrs 12 00 hrs 24 00 hrs
次要结局
- To assess the Bioequivalence on Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division Dhamrai Dhaka Bangladesh with Diovan HCT Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Distributed by Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936(21 time points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited