NCT01596010已完成1 期
Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Area under the Curve (0-t)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL
- •Non-smoking
- •Body Mass Index (BMI) maximum 35.0 kg/m^2
- •Able to understand, read and speak German fluently
- •Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination
- •Willing to abstain from intake of caffeine containing food and beverages within 48 hours before drug administration
排除标准
- •Known or suspected allergy to trial products or related products
- •Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration
- •Known, suspected or history of breast cancer
- •Known or suspected estrogen dependent neoplasia e.g. endometrial cancer
- •Abnormal genital bleeding of unknown aetiology
- •Known insulin dependent as well as non-insulin dependent diabetes mellitus
- •Positive test for HIV (human immunodeficiency virus) and/or hepatitis B and C
- •Systolic blood pressure (BP) above or equal to 160 mm Hg and/or diastolic BP above or equal to 100 mm Hg, currently treated or untreated
研究组 & 干预措施
New formulation
Experimental
干预措施: 2 mg estradiol / 1 mg norethisterone acetate (NETA) (Drug)
Old formulation
Active Comparator
干预措施: 2 mg estradiol / 1 mg norethisterone acetate (NETA) (Drug)
结局指标
主要结局
Area under the Curve (0-t)
时间窗: Up to 72 hours after trial product administration
Cmax, maximum concentration
时间窗: Up to 72 hours after trial product administration
次要结局
- Incidence of adverse events (AEs)(Week 8)
- Terminal rate constant(Up to 72 hours after trial product administration)
- Area under the curve from time zero to infinity(Up to 72 hours after trial product administration)
- Time to maximum (tmax)(Up to 72 hours after trial product administration)
- Terminal half-life (t½)(Up to 72 hours after trial product administration)
研究者
相似试验
已完成
1 期
Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01526941Novo Nordisk A/S27
已完成
1 期
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male SubjectsAcquired Bleeding DisorderAcquired HaemophiliaCongenital Bleeding DisorderCongenital FVII DeficiencyGlanzmann's DiseaseHaemophilia A With InhibitorsHaemophilia B With InhibitorsHealthyNCT01561417Novo Nordisk A/S28
已完成
1 期
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy SubjectsHealthyDiabetesNCT01490099Novo Nordisk A/S37
已完成
1 期
Comparison of Two Liraglutide Formulations in Healthy VolunteersHealthyDiabetesNCT01508897Novo Nordisk A/S22
已完成
1 期
Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)HealthyDiabetesNCT01530048Novo Nordisk A/S34