CTRI/2025/01/079590已完成不适用
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Single Period Parallel Truncated Oral Bioequivalence Study Comparing Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by VS International With Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd In Adult Patient With Mild And Moderate Iron Deficiency Anemia Under Fed Conditions
Assist Pro1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年2月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by VS International with Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd
研究概览
简要总结
An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Single-Period, Parallel, Truncated, Oral Bioequivalence Design In Adult, Patient With Mild And Moderate Iron Deficiency Anemia, Under Fed Conditions
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
If needed the study will be conducted as batch wise
In each period subjects will be housed in the clinical facility for at least 11 00 hrs pre dose to 72 00
hrs post dose
After an overnight fasting of at least 08 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 03 00 06 00 12 00 24 00 36 00 and 48 00 plus or minus 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
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
- •Adult patients with iron deficiency anemia of age between 18 to 45 years and Body Mass Index BMI ranges between 18 50 kg m2 to 30 00 kg m2 according to the formula of BMI weight kg height m2 Diagnosed iron deficiency anemia based on two criteria a hemoglobin level below 110 g L in men and women but above 80 g L Mild Hemoglobin 10 0 g dL to lower limit of normal Moderate Hemoglobin 8 0 to 10 0 g dL b serum ferritin levels below 30 µg L Patients who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Patients 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 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 and Standard breakfast Dosing day 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 for female Patients 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 If the Patients 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 Patient s last study related visit for eligible Patients 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 Patient becomes sexually active.
排除标准
- •Evidence of allergy or known hypersensitivity to Iron III Hydroxide Polymaltose 100mg Tablet or its inactive ingredients Administration of any iron containing drugs during the last 3 months History of erythropoietin drugs administration Patients with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus pre existing gallbladder disease and Heme metabolism disorders eg sideroachrestic anaemia lead anaemia thalassaemia Other types of anemia apart from iron deficiency will be excluded from enrollment in the study Malignant diseases including blood and lymphoid tissue disorders leukemia Hodgkin disease myelodysplastic syndrome myeloma etc at screening or in the past medical history provided that the remission was less than 5 years before screening Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Blood loss leading to hemodynamic instability The necessity of parenteral iron therapy ie the following cases a impaired absorption in case of an intestinal pathology enteritis coeliac disease malabsorption small intestinal resection stomach resection including the duodenum b exacerbation of gastric or duodenal ulcer c the necessity of quick iron saturation eg in patients with iron deficiency anaemia with upcoming surgery d continuous vast blood loss and other causes at the discretion of the investigator 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 foods within 48 00 hours prior to clinic admission and throughout the entire study Patients 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 Patients who have taken any unusual diet for whatever reason eg low salt for 48 00 hours prior to dosing and throughout the study Patient 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 Positive results for alcohol test prior to check in 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 Patients demonstrating a positive pregnancy screen Female Patients 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 Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by VS International with Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd
时间窗: 23 Time points | minus 02 00 hrs minus 01 00 hrs 00 00 hrs 00 50 hrs 01 00 hrs 01 50 hrs 02 00 hrs 02 50 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 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs 72 00 hrs
次要结局
- To assess the Bioequivalence on Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by VS International with Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd(23 Time points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited
研究点 (1)
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