An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Bioequivalence Study in Healthy, Adult,Human, Male Subjects Under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC)
研究概览
简要总结
An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult,human, male subjects under fasting conditions.
详细描述
This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover bioequivalence study in healthy, adult, human, male subjects under Fasting conditions. 72 healthy male adults were enrolled. A washout period of 7 days was maintained between the successive dosing days.One capsule containing mycophenolate mofetil 250 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first two hours after dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged between 18 and 50 years (including both).
- •Subjects' weight within the normal range according to normal values for the Body
- •Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.
- •Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
- •Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •Subjects having clinically acceptable chest X-Ray (PIA view).
- •Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •Subjects having negative alcohol breath test.
- •Subjects willing to adhere to the protocol requirements and to provide written informed consent.
排除标准
- •The subjects were excluded from the study, if they meet any of the following criteria:
- •Hypersensitivity to Mycophenolate Mofetil or related drugs.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •History or presence of significant alcoholism or drug abuse in the past one year.
- •History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).
- •History or presence of asthma, urticaria or other significant allergic reactions.
- •History or presence of significant gastric and/or duodenal ulceration.
- •History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets or capsules.
- •Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.
- •Major illness during 3 months before screening.
- •Participation in a drug research study within past 3 months.
- •Donation of blood in the past 3 months before screening.
- •Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- •History or presence of significant easy bruising or bleeding.
- •History or presence of significant recent trauma.
研究组 & 干预措施
Mycophenolate Mofetil
Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
干预措施: Mycophenolate Mofetil (Drug)
Cellcept
Cellcept 250 mg capsules of Roche Laboratories Inc.
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Area Under Curve (AUC)
时间窗: Pre-dose, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose
次要结局
未报告次要终点