A Double Blind Balanced Randomized Single Dose Two Treatment Parallel Truncated Bioequivalence Study Comparing Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL by Jodas Expoim Private Limited Telangana Manufactured For Nova Pharmaceuticals Australasia Pty Ltd With Ferinject Injection Ferric Carboxymaltose 1000mg per 20mL Manufactured by Vifor Pharma Pty Ltd Level 8 80 Dorcas Street Southbank Melbourne Vic 3006 Australia in Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence on Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL by Jodas Expoim Private Limited Telangana Manufactured for Nova Pharmaceuticals Australasia Pty Ltd with FERINJECT Injection Ferric carboxymaltose 1000mg per 20mL Manufactured by Vifor Pharma Pty Ltd Australia In Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions
研究概览
简要总结
At least 44 number of healthy Adult Patients With Iron DeficiencyAnaemia will be recruited to evaluate the Bioequivalence of Test product withthe Reference product
In each period patients will be housed in the clinical facility for atleast 11 00 hours pre dose to 72 00 hours post dose
In each period, after an overnight fasting of at least 08 00 hrs, in themorning a single infusion of either the test product T or reference product Rwill be administered as per the randomization schedule up to 15 to 30 minutes atambient temperature, to the patients to the patient in the supine position,under the supervision of Investigator or Medical Officer and trained studypersonnel including the Quality Assurance auditor or monitors
Blood pressure, radial pulse rate, body temperature, and wellbeingstatus will be enquired and recorded at pre-dose 00.00 hour within 75 minutesof before dosing and at 01 00 hrs 02 00 hrs 04 00 hrs 06 00 hrs 08 00 hrs 12 0024 00 hrs 36 00 hrs 48 00 hrs plus or minus 60 minutes post dose
Physical examination and vitals will be recorded before check in checkout 72 00 hrs and at any time if necessary.
Monitoring for adverse events will be done throughout the study periodin clinical phase
研究设计
- 研究类型
- Ba/be
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
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 ranging between 18 50 kg m2 to 30 00 kg m2 according to the formula of BMI weight kg height m2 and body weight of 50 kg or above Patients should have prescriptions for treatment with ferric carboxymaltose injections Diagnosed iron deficiency anemia based on two criteria a Hemoglobin level below 12 g dL in men and women b Serum ferritin levels below or equal to 100 ng per mL or below or equal to 300 ng per mL when TSAT is less than or equal to 30 percentage 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 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 an 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 gynecological examination and breast examination for female patients during the study period 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 the study period If the patient 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 patients last study related visit for eligible patients only if applicable has a negative serum pregnancy test and is of Non childbearing potential defined as At least 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 with a low failure rate of less than 1 percent 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 Ferric Carboxymaltose excipients or similar product Clinically significant or labile hypertension Blood loss leading to hemodynamic instability Recent parenteral iron within the last 3 to 6 months Positive results for Allergic test prior to check in of study period Patients 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 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 that may affect pharmacokinetic results 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 of this study period Positive results for alcohol test prior to check in of study 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 patients demonstrating a positive pregnancy screen Female patients 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 Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL by Jodas Expoim Private Limited Telangana Manufactured for Nova Pharmaceuticals Australasia Pty Ltd with FERINJECT Injection Ferric carboxymaltose 1000mg per 20mL Manufactured by Vifor Pharma Pty Ltd Australia In Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions
时间窗: 27 time points | minus 02 00 hrs minus 01 00 hrs 00 00 hrs 00 08 hrs 00 16 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 16 hrs 01 33 hrs 01 50 hrs 01 67 hrs 02 00 hrs 02 50 hrs 03 00 hrs 04 00 hrs 05 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs
次要结局
- To monitor the safety and tolerability of testproduct comparing with the reference product in Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions(27 time points)