CTRI/2020/12/029469暂停1 期
A Phase I, randomized, open-label, 2-way crossover, clinical study in healthy female volunteers, to evaluate Safety and Pharmacokinetics of Briogyn (Follitropin alfa, Cadila HealthCare) and Gonal-f (Follitropin alfa, Merck Serono)
PSK Pharma LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1Subjects who have used oral contraceptives for at least 3 months before study entry and are prepared to stop taking oral contraception from screening and to use effective non-hormonal methods of birth control until completion of 1 menstrual cycle after the last dose administration
- •2Women of child bearing potential must agree to use effective non-hormonal contraception for birth control until completion of 1 menstrual cycle after the last dose administration
- •3Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception
- •4Subjects with both ovaries
- •5Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission
- •6Subjects who are healthy as determined by pre study medical history, physical examination and 12-Lead electrocardiogram (ECG)
- •7Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the investigator
- •8Subjects who are able and willing to give written informed consent
排除标准
- •1Subjects who do not conform to the above inclusion criteria
- •2Subjects with polycystic ovary syndrome
- •3Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size
- •4Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome)
- •5Subjects with impaired thyroid function (treated or untreated)
- •6Subjects with a history of malignant disease
- •7Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper limit of normal reference range
- •8Subjects with other clinically relevant findings (ECG, blood pressure, physical, laboratory examination)
- •9Subjects with a smoking history of more than 5 cigarettes per day
- •10Subjects with evidence of abuse of drugs or alcoholic beverages
- •11Subjects with a positive screen for hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus 1/2
- •12Subjects who have participated in a clinical trial within the 3 months prior to this study
- •13Subjects who are unlikely to co-operate with the requirements of the study
- •14Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to study day -1
- •15Subjects who are pregnant, lactating or attempting to become pregnant
- •16Subjects with any medical condition (including a known predisposition to porphyria) that, in the opinion of the investigator, could interfere with safety of the subject or interfere with the objectives of the study
- •17Subjects who are vegans or have medical dietary restrictions
研究者
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