NCT00759759已完成1 期
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study Comparing the Bioavailability of a Morphine Sulfate Sustained Release Capsule 1 x 200mg to KADIAN 2 x 100mg Capsules Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Actavis Inc.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum Plasma Morphine Concentration
研究概览
简要总结
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x 100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered after a 10-hour overnight fast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Subject must be a male or non-pregnant, non-breast-feeding female.
- •Subject must be between 18 and 50 years of age inclusive.
- •Subject's body weight should be within +/- 15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table and weigh a minimum of 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, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
- •Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion 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 to the study site for any outpatient visits.
排除标准
- •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 or clinical laboratory results at screening.
- •History or presence of allergic or adverse response to the study drug 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 first dose of study medication.
- •Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.
- •Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.
- •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 60 days prior to the first dose of study medication.
- •Has a history of substance abuse (including alcohol) in the past 5 years.
- •Is a female with a positive pregnancy test result.
- •Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
- •Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.
研究组 & 干预措施
2
Other
Treatment B (reference product) followed by Treatment A (test product)
干预措施: morphine sulfate sustained-release capsules (Drug)
2
Other
Treatment B (reference product) followed by Treatment A (test product)
干预措施: KADIAN (morphine sulfate sustained-release) capsules (Drug)
1
Other
Treatment A (test product) followed by Treatment B (reference product)
干预措施: morphine sulfate sustained-release capsules (Drug)
1
Other
Treatment A (test product) followed by Treatment B (reference product)
干预措施: KADIAN (morphine sulfate sustained-release) capsules (Drug)
结局指标
主要结局
Maximum Plasma Morphine Concentration
时间窗: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
次要结局
- Time of Maximum Plasma Morphine Concentration(0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose)
- Area Under the Curve to Infinity for Plasma Morphine(0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose)
- Area Under the Curve to the Last Measurable Time Point for Plasma Morphine(0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose)
研究者
研究点 (1)
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