ACTRN12619000171112已完成1 期
Randomized, Single Dose, Two Way, Cross-Over Open-Label Study To Determine The Pharmacokinetic Parameters Of AFT Pharmaceuticals Ltd Test Product Ferro-C (325 mg Ferrous Sulfate And 562.4 mg Sodium Ascorbate Per Modified Release Tablet) Relative To BGP Products Pty Ltd Reference Product FERRO-GRAD C® (325 mg Ferrous Sulfate And 562.4 mg Sodium Ascorbate Per Modified Release Tablet), After Oral Administration In 24 Healthy Adult Volunteers Under Fasting and Fed Conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Male or female subjects aged between 18 and 50 years, inclusive, on the day of consent.
- •Voluntarily provide written informed consent before the initiation of any study-related procedures.
- •Have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m2.
- •Have no significant disease (asthma, peptic or gastric ulcer, sinusitis, pharyngitis, gastrointestinal disease, pulmonary disease, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, infective, dermatologic or immunological disorders) as determined by medical history, physical examination and laboratory tests.
- •Have negative HIV and hepatitis B & C test results.
- •Be able and willing to abstain from caffeine-containing beverages (e.g. coffee, soda, energy drinks or tea), caffeine-containing food (e.g. chocolate), and alcohol for at least 24 hours prior to study drug administration until the last study sample is collected in each period.
- •Be able and willing to abstain from any food or beverages containing grapefruit for at least 7 days prior to study drug administration until the last study sample is collected in each period.
- •Be able and willing to abstain from prescription drugs (not including oral contraceptives and the study medication) within at least 14 days prior to study drug administration and during the study or have used over-the-counter drugs or herbal products within at least 7 days prior to study drug administration and during the study.
- •Be able and willing to abstain from vitamins taken for nutritional purposes for at least 2 days prior to study drug administration until the last study sample is collected in each period.
- •Be able and willing to abstain from smoking throughout the whole duration of the study
- •Have a medically acceptable normal 12-lead ECG.
- •No parenteral or oral iron for last 2 weeks before study drug administration.
排除标准
- •Female who are pregnant or nursing (not applicable for male subjects).
- •Female of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral oophorectomy (not applicable for male subjects).
- •Female of childbearing potential who are unwilling to undergo a urine pregnancy test (not applicable for male subjects).
- •Have an alcohol intake in excess of 14 units per week for females and 21 units per week for males.
- •Have a history of drug abuse or positive test results for drug abuse during screening.
- •Unwilling to abstain from smoking throughout the whole duration of the study
- •Unable and refuse to abstain the used prescription drugs (not including oral contraceptives and the study medication) within at least 14 days prior to study drug administration and during the study or have used over-the-counter drugs or herbal products within at least 7 days prior to study drug administration and during the study.
- •Unable and refuse to abstain the use of vitamins taken for nutritional purposes within
- •at least 2 days prior to study drug administration until the last study sample is collected in each period.
- •Unable and refuse to abstain to consume grapefruit containing foods or beverages within at least 7 days or caffeine containing foods or beverages within at least 24 hours prior to study drug administration until the last study sample is collected in each period.
- •Currently, or in last 80 days, participating in a clinical trial involving another study drug.
- •Have donated blood or blood products within 60 days prior to study drug administration.
- •Have a clinically significant abnormal laboratory test (as determined by the Investigator), Hb test which deviated outside the 5% of below limit of reference range or laboratory results of liver or kidney function tests (creatinine, urea and ALP will be accepted if below reference range, total protein and albumin accepted if above reference range) are outside the reference range
- •Be on a special diet (for example is vegetarian).
- •Unable and refuse to abstain to engage in strenuous exercise within at least 24 hours prior to study drug administration until the last sample is collected in each study period.
- •Have at screening examination a pulse outside the normal range of (60-100 beat per minute) or a body temperature outside the normal range of (35.0-37.2 degrees celsius) or a respiratory rate outside the normal range of (14-20 breath per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg.
- •Unable and refuse to abstain to consume any beverages or food containing alcohol for at least 24 hours prior to study drug administration until the last study sample is collected in each period.
- •Have a history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
- •Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant’s best interests to participate in this study.
- •Subject is a heavy smoker (more than 10 cigarettes per day).
- •Acute infection within one week preceding study drug administration.
- •Subject having rela
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