NCT01380496已完成1 期
Randomized, 3-Way Crossover, Comparative Bioequivalence Study of Par Pharmaceutical Inc. (USA) and Oclassen Pharmaceuticals Inc. (USA)(Monodox(R)) Doxycycline Monohydrate Equivalent to 100 mg Doxycycline Administered as a Single Dose of 100 mg 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
- Bioequivalence
研究概览
简要总结
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg.
详细描述
To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fed and fasting 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
- •Males, non-smokers, between 18-55 years of age
- •Subjects' weight will be within 15% of their ideal weight based on the Table of "Desirable Weight of Adults", Metropolitan Life Insurance Company,
- •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 abnormalities found during medical screening
- •Any clinically significant history of ongoing gastrointestinal problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. chronic diarrhea, inflammatory bowel diseases).
- •Clinically significant illnesses within 4 weeks of the administration of study medication.
- •Abnormal laboratory test judged clinically significant.
- •ECG or vital signs abnormalities (clinically significant).
- •History of allergic reactions to doxycycline or other related drugs (e.g., chlortetracycline, demeclocycline, minocycline and tetracycline).
- •History of allergic reactions to heparin.
- •Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
- •Positive urine drug screen (see section VIII) at screening
- •Positive testing for hepatitis B, hepatitis C or HIV screening.
- •Use of an 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) with 56 days prior to 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 (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%)
- •Recent history of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), crack) 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 (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine).
- •Subjects who have undergone clinically significant surgery 4 weeks prior to the administration of the study medication.
- •Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
B
Active Comparator
Subjects received the Oclassen Pharmaceuticals Inc. formulated product.
干预措施: doxycycline monohydrate (Drug)
C
Active Comparator
Subjects received the Oclassen Pharmaceuticals Inc. formulated product.
干预措施: doxycycline monohydrate (Drug)
A
Experimental
Subjects received the Par formulated product
干预措施: doxycycline monohydrate (Drug)
结局指标
主要结局
Bioequivalence
Comparable food effect; The ratio of least-squares meansof the test to reference of AUCo-t, AUC -inf and Cmax should be within 80% to 125%.
次要结局
未报告次要终点
研究者
研究点 (1)
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