3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
研究概览
简要总结
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
详细描述
Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.
Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult males aged 18 to 75 with a documented diagnosis of hypogonadism
排除标准
- •Normal testosterone levels
- •Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study
研究组 & 干预措施
QuickShot™ - 100 mg Treatment A
QuickShot™Testosterone - Auto-injector device for SC use
干预措施: QuickShot™ - 100 mg Treatment A (Drug)
QuickShot™ - 50 mg Treatment B
QuickShot™Testosterone- Auto-injector device for SC use
干预措施: QuickShot™ - 50 mg Treatment B (Drug)
Delatestryl 200 mg IM Treatment C
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
干预措施: Delatestryl 200 mg IM Treatment C (Drug)
结局指标
主要结局
The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
时间窗: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The area under the curve from time zero to last quantifiable concentration \[AUC (0-t)\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
时间窗: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The maximum observed plasma concentration \[Cmax\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
时间窗: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
The average concentration \[Cavg\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
次要结局
- Number of Patients in the PK Parameter Category(6 weeks)