ACTRN12613000943741已完成1 期
A single dose, randomized, blinded, pilot bioequivalence study of tibolone tablets in a 2 way crossover comparison against the innovator tibolone tablet conducted under fasting conditions in healthy female volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
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
- Female
入选标准
- •Healthy Females
- •Aged between 18 and 55
- •Non-smoker
- •BMI between 19 and 30
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, bood pressure and laboratory tests
- •Not currently using any prescribed hormonal contraceptive
- •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
- •History of depression, anxiety, obsessive-compulsive disorder, or post-traumatic stress syndrome
- •Pregnant, breast-feeding or have any obstetric or gynaecological conditions
- •Who have ever had an ectopic pregnancy
- •Who do not agree to using alternative forms of contraception or abstain from sexual activity during the study
- •Who have a history of breast cancer
- •With a history or family history of thrombophilia
- •Sensitivity to tibolone, any synthetic steroid medicines, excipients of tibolone
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •Who are lactose intolerant
- •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
相似试验
已完成
1 期
Comparative assessment of the absorption of a generic formulation of metoprolol tablet against the innovator metoprolol tablet conducted under fasting conditions in healthy male and female volunteersPilot bioequivalence study conducted in healthy volunteers comparing two formulations of metoprolol with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, metoprolol belongs to a class of medicines called beta-selective adrenoceptor blocking agent for the treatment of hypertension, angina pectoris and heart failure.Pilot bioequivalence study conducted in healthy volunteers comparing two formulations of metoprolol with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, metoprolol belongs to a class of medicines called beta-selective adrenoceptor blocking agent for the treatment of hypertension, angina pectoris and heart failure.Other - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12613001128785Zenith Technology Corp Ltd12
已完成
1 期
Comparative assessment of the absorption of 3 generic formulations of isotretinoin capsules against the innovator isotretinoin capsule in a pilot study conducted under fasting conditions in healthy male volunteersACTRN12615000569505Zenith Technology Corp Ltd16
已完成
1 期
Comparative assessment of the absorption of an Iron Polymaltose tablet against an innovator product conducted in iron deficient participants under fed conditions with diet control (low iron and low fat).Iron DificiencyDiet and Nutrition - Other diet and nutrition disordersBlood - AnaemiaACTRN12623001001684Zenith Technology Corporation Limited24
已完成
1 期
Comparative assessment of the absorption of a generic formulation of Iron Polymaltose tablet against the innovator Maltofer tablet conducted in iron deficient participants under fed conditions with diet control.Iron DificiencyBlood - AnaemiaDiet and Nutrition - Other diet and nutrition disordersACTRN12623000530628Zenith Technology Corporation Limited12
已完成
1 期
Comparative assessment of the absorption of a generic formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide tablet against the innovator iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide tablet conducted under fasting conditions with diet control in healthy male volunteersIron deficiencyBlood - AnaemiaDiet and Nutrition - Other diet and nutrition disordersACTRN12620001227987Zenith Technology Corporation Limited24