A Randomized, Open-label, Single-dosing, 2x2 Crossover Phase 1 Study to Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- AUC7-t of Leuprolide
研究概览
简要总结
The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers
详细描述
The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening.
- •Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.
排除标准
- •Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- •Those whose plasma AST and ALT exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- •Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
- •Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
研究组 & 干预措施
A
After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)
干预措施: leuprorelin acetate 3.75mg (Drug)
B
After a single administration of PT105 (leuprorelin acetate 3.75mg), a single administration of PT105R (leuprorelin acetate 3.75mg)
干预措施: leuprorelin acetate 3.75mg (Drug)
结局指标
主要结局
AUC7-t of Leuprolide
时间窗: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
AUC7-t
AUCt of Leuprolide
时间窗: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
AUCt
AUCinf of Leuprolide
时间窗: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
AUCinf
Cmax of Leuprolide
时间窗: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Cmax
次要结局
- Tmax of Leuprolide(0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr)
- t1/2 of Leuprolide(0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr)