Single Dose Two-Way Crossover Fasted Bioequivalence Study of Minocycline 100 mg Capsules in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The purpose of this study was to determine the bioequivalence of Minocycline formulations after administration of single doses to normal healthy subjects under fasted conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
详细描述
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing minocycline 100mg tablets of Ranbaxy pharmaceuticals inc with Minocin 100mg capsules of in healthy, adult, human, subjects under fasting conditions.
A total of 28 non-smoking subjects (16 men and 12 women) were included in this study, of which 28 finished the study according to the protocol,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females between 18 and 45 years of age inclusive.
- •Informed o'f the nature of the study and given written informed consent.
- •Have a body weight within 15 % of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.
排除标准
- •Hypersensitivity to Minocycline (Minocin®), or other antibiotics.
- •Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- •Recent history of mental illness, drug addiction, drug abuse or alcoholism.
- •Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- •Received an investigational drug within the 4 weeks prior to study dosing.
- •Currently taking any prescription medication, except oral contraceptives, within the 7 days pr/or to study dosing or over-the-counter medication within 3 days of study dosing. This prohibitor~ does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physic/an2
- •Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
- •If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
- •Females of child bearing potential must use a 'medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
- •Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection' or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
- •Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
研究组 & 干预措施
1
Minocycline 100 mg tablets of ranbaxy
干预措施: Minocycline 100mg Tablets (Drug)
2
Minocin 100mg tablets
干预措施: Minocycline 100mg Tablets (Drug)
结局指标
主要结局
Bioequivalence
次要结局
未报告次要终点