CTRI/2009/091/000518已完成1 期
A Single dose, Open-Label, Randomized, 2-Way Crossover Bioequivalence Study of UlipristalAcetate 30 mg Tablets Manufactured at LEON Farma (Spain) and Cardinal Health France (France)Under Fasted Conditions in Healthy Female Volunteers
HRA Pharma0 个研究点目标入组 54 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Healthy, female subjects 18 to 35 years of age (inclusive).
- •· Body mass within 10% of the ideal mass in relation to height and age, according to the
- •BMI (normal range for BMI: 18.5 ? 25 kg/m2)
- •· Regularly menstruating women: cycles of 28±3 days duration
- •· No current use of hormonal contraception and having had at least one complete
- •menstrual cycle (2 menses) since having stopped hormonal contraception
- •· Willing to not use hormonal methods of contraception until study completion
- •· At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
- •· Able to read and give voluntary, written informed consent, and agree to observe all
- •study requirements (the subject needs to be available for follow-up over the next 6
- •· Willing to abstain from any acts of unprotected intercourse or having a valid nonhormonal
- •IUD in place during participation in the study
- •· Non-smoker
排除标准
- •Evidence of psychiatric disorder, antagonist personality, poor motivation, emotional or
- •intellectual problems likely to limit the validity of consent to participate in the study or limit
- •the ability to comply with protocol requirements
- •· History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to
- •other substances of abuse.
- •· Use of any medication, prescribed or over-the-counter, within two weeks prior to the first
- •administration of study medication except if this will not affect the outcome of the study in
- •the opinion of the investigator.
- •Protocol 2914-011
- •DRD_FO_GB_037_03 VERSION: 1.1 ? Date: 2009-02-03 15
- •· Impaired hypothalamic-pituitary-adrenal reserve.
- •· Participation in another study with an experimental drug within eight weeks before the first
- •administration of study medication. Participation to more than 3 experimental drug studies
- •within 12 months before the beginning of the study.
- •· A major illness during the three months before commencement of the screening period.
- •· Undiagnosed genital bleeding.
- •· Relevant history or laboratory or clinical findings indicative of acute or chronic disease,
- •likely to influence the study outcome.
- •· Donation or loss of blood equal to or exceeding 500 mL during the eight weeks before the
- •first administration of study medication. Donation of more than 1.5 L of blood within the 10
- •months before the beginning of the study.
- •· Diagnosis of hypertension made during the screening period or current diagnosis of
- •hypertension.
- •· Resting pulse rate of > 100 beats per minute or < 45 beats per minute during the screening
- •period, either supine or standing.
- •· Currently pregnant as confirmed by positive urine pregnancy test (b-HCG) either positive or
- •not performed or lactation
- •· Currently breast-feeding
- •· Current use of hormonal contraception
- •· Current use of progesterone intrauterine device (IUD)
- •· Positive urine screen for drugs of abuse
研究者
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