An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Ferric Maltol 30 mg Capsules Manufactured by BDR Pharmaceuticals International Private Limited India With Feraccru Ferric Maltol 30 mg Capsules Manufactured by Norgine B V Antonio Vivaldistraat 150 Amsterdam Netherlands 1083 Hp In Healthy Adult Human Subjects under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To assess the Bioequivalence of Ferric Maltol 30 mg Capsules Manufactured by BDR Pharmaceuticals International Private Limited India With Feraccru® Ferric Maltol 30 mg Capsules Manufactured by Norgine B V Antonio Vivaldistraat 150 Amsterdam Netherlands 1083 Hp In Healthy Adult Human Subjects Under Fasting Conditions
研究概览
简要总结
42 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 42 subjects in period I alone.
Note
If needed the study will be conducted as batch wise.
Demographic data, medical and medication history, physical examination, 12 lead ECG, haematology, biochemistry, serology, Serum Ferritin, Serum iron, urine routine analysis, additionally for females serum pregnancy test, hormone assay FSH will be done within 21 days and a chest X-ray within 06 months prior to check in
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
A washout period of at least 40 days will be maintained between each dosing period
Subjects will be served dinner on the day of check-in for each period. Thereafter, subjects will fast for at least 10.00 hours prior to dosing
Standard meals will be provided at 04.00, 08.00, 12.00, 24.00, 28.00, 32.00 and 36.00 hours post-dose respectively. All meal plans will be identical in all the periods of the study
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, 04.00, 06.00, 08.00, 12.00 and 24.00 hours (± 60 minutes) post dose
Physical examination and vitals will be recorded before check-in, check out (48.00 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 per m2 to 29.99 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 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 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 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 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 Ferric Maltol 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 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 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 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 of Ferric Maltol 30 mg Capsules Manufactured by BDR Pharmaceuticals International Private Limited India With Feraccru® Ferric Maltol 30 mg Capsules Manufactured by Norgine B V Antonio Vivaldistraat 150 Amsterdam Netherlands 1083 Hp In Healthy Adult Human Subjects Under Fasting Conditions
时间窗: 24 Time points | minus 02 00 hrs minus 01 00 hrs 00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 25 hrs 02 50 hrs 02 75 hrs 03 00 hrs 03 50 hrs 04 00 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 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)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited