A Single-Dose, Replicate, Comparative Bioavailability Study of Two Formulations of Mycophenolate Mofetil 500 mg Tablets Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration
研究概览
简要总结
The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a single-dose in healthy subjects under fasting 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
- •Healthy, non-smoking male subjects, 18 years of age or older.
- •Healthy, non-smoking post-menopausal or surgically sterile females 18 years of age or older.
- •BMI ≥ 19 and ≤
- •Negative for:
- •Hepatitis B surface antigen and Hepatitis C antibody.
- •Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
- •Urine cotinine test
- •Serum HCG consistent with pregnancy (females only)
- •No significant diseases or clinically significant findings in a physical examination.
- •No clinically significant abnormal laboratory values.
- •No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
- •Be informed of the nature of the study and given written consent prior to receiving any study procedure.
- •Females who participate in this study must be unable to have children:
- •post-menopausal for at least 1 year - no menstrual cycle for 12 months and LH and FSH levels judged by a physician to be consistent with post-menopausal status.
- •Proof of surgical sterility.
- •Females who participate in this study are not pregnant and/or non-lactating.
排除标准
- •Known history or presence of any clinically significant medical condition.
- •Known or suspected carcinoma.
- •Known or suspected increased susceptibility to infection.
- •Known history or presence of active tuberculosis (TB).
- •Results of a previous TB skin test greater than 5 mm in diameter.
- •Lived in or traveled, during the last 8 weeks, to a country defined by the Public Health Agency of Canada as having WHO estimated sputum smear positive pulmonary TB rate of 15 per 100,000 or higher.
- •Known history or presence of:
- •Hypersensitivity or idiosyncratic reaction to mycophenolate mofetil and/or any other drug substances with similar activity.
- •Alcoholism within the last 12 months.
- •Drug dependence and/or substance abuse.
- •Use of tobacco or nicotine-containing products within the last 6 months.
- •On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
- •Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
- •Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 499 mL of blood in the previous 45 days OR Donated more than 499 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
- •Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
- •Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
- •Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
- •Difficulty fasting or consuming the standard meals.
- •Do not tolerate venipuncture.
- •Unable to read or sign the ICF.
研究组 & 干预措施
Cellcept® (reference) First
CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
干预措施: CellCept® Tablets (Drug)
Mycophenolate Mofetil (test) First
Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
时间窗: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-t
次要结局
未报告次要终点