NCT00652704已完成1 期
Randomized, Open-Label, 3-Way Crossover, Comparative Bioavailability Study of Par's and Oclassen's (Monodox) Doxycycline Monohydrate Capsules Administered as 1 x 100 mg Capsule in Healthy Adult Males Under Fasting and Fed 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
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rate and extent of absorption
研究概览
简要总结
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
详细描述
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline by Par Pharmaceutical Inc., USA (test) versus Monodox by Oclassen Pharmaceuticals, Inc., USA (reference) administered as a 1 x 100 mg capsule under fasting and fed conditions.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects will be males, non-smokers
- •Between 18 and 55 years of age
- •Subjects weight will be within 15% of their ideal body weight, based on Table of "Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983
- •Subjects should read, sign and date an Informed Consent Form prior to any study procedures
- •Subjects must complete all screening procedures within 28 days prior to the administration of the study medication
排除标准
- •Clinically significant anormalities found during medical screening
- •Any clinically significant history of ongoing problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs of drugs
- •Clinically significant illnesses within 4 weeks of the administration of study medication
- •Abnormal laboratory tests judged clinically significant
- •ECG or vital sign abnormalities (clinically significant)
- •History of allergic reactions to heparin
- •Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study
- •History of severe allergies or hay fever
- •Active asthma or bronchospasm
- •Positive urine drug screen at screening
- •Positive testing for hepatitis B, hepatitis C or HIV at screening
- •Use of investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication
- •Recent donation of plasma (500 mL) within 7 days or recent donation or significant loss of whole blood (450 mL) within 56 days prior to the administration of the study medication
- •History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day
- •Recent history of drug abuse or use of illegal drugs: soft drugs (marijuana, pot) use within 3 months of the screening visit and hard drugs (cocaine, PCP, crack) use within 1 year of the screening visit
- •Subjects who have taken prescription medication 14 days preceding administration of study medication or over-the-counter products 7 days preceding administration of study medication, except for topical products without systemic absorption
- •Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication
- •Subjects who have undergone clinically significant surgery within 4 weeks prior to the administration of the study medication
- •Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
研究组 & 干预措施
A
Experimental
Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions
干预措施: Doxycycline Monohydrate (Drug)
C
Experimental
Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions
干预措施: Doxycycline Monohydrate (Drug)
B
Active Comparator
Subjects received the reference product, Monodox (Oclassen) under fed conditions
干预措施: Monodox (Drug)
结局指标
主要结局
Rate and extent of absorption
时间窗: 72 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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