A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Mycophenolate Mofetil Capsules Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC0-inf
研究概览
简要总结
The objective of this study was to compare the oral availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available reference product, CellCept® 250 mg capsule administered to healthy subjects under fed conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must satisfy the following criteria to be considered for study participation:
- •Subject must be male or non-pregnant, non-breast-feeding female
- •Subject must be at least 18 years of age
- •Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive, and body weight should be at least 50 kg (110 lbs)
- •Female Subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, double barrier (condom with spermicide, diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
- •Subject must voluntarily consent to participate in this study and provide their written informed consent prior to the start of any study-specific procedures.
- •Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return for any outpatient visits.
排除标准
- •Subjects may be excluded for any of the following:
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
- •Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening.
- •History or presence of allergic or adverse response to mycophenolate mofetil or related drugs.
- •Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
- •Has donated blood or plasma within 30 days prior to the first dose of study medication.
- •Has participated in another clinical trial within 30 days prior to the first dose of study medication.
- •Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
- •Has used any prescription medication, including hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
- •Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
- •Has smoked or used tobacco products within 90 days prior to the first dose of study medication.
- •Is a female with a positive pregnancy test result.
- •Female who has used implanted hormonal contraceptives anytime during the 6 months prior to study start.
- •Has an intolerance to venipuncture.
- •Has difficulty fasting or consuming standard meals.
- •Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates)
- •Has a history of drug or alcohol abuse.
- •Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.
研究组 & 干预措施
Test (mycophenolate mofetil) First
Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
干预措施: Mycophenolate Mofetil (Drug)
Reference (CellCept®) First
CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
干预措施: CellCept® (Drug)
结局指标
主要结局
AUC0-inf
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-inf - Area under concentration-time curve from time zero to infinity (extrapolated)
Cmax
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on Cmax - Maximum Drug Concentration
AUC0-t
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-t - Area under concentration-time curve from time zero to time of last non-zero concentration
次要结局
未报告次要终点