ACTRN12614000267651已完成1 期
A single-dose, single-blinded, balanced, randomised, three-treatment, three-period, three-sequence pilot bioequivalence study of doxycycline delayed release capsules in a 3 way crossover comparison against the innovator doxycycline delayed release tablet conducted under fasting conditions in healthy male and female volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Healthy males and non-pregnant females
- •Aged between 18 and 55
- •Non-smoker
- •BMI between 19 and 30
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- •Able to provide written informed consent
排除标准
- •Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
- •Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives
- •Used substances known to be strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erthyomycin, fluconazle and ketoconazole) or strong inducers of CYP enyzmes (such as barbiturates, carbamazepine, glucocortcoids, phenytoin and rifampin) within 28 days of study starts
- •Sensitivity to doxycycline, any tetracyclines or other antibiotic medicines, excipients of doxycycline
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •Females who are breastfeeding or are planning to start a family within 60 days of dosing
- •Smoker (anyone who has smoked in the last 6 months)
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
- •Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk.
研究者
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