A RANDOMIZED, OPEN LABEL, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE,SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OF LEUPROLIDE ACETATE 7.5 MG DEPOT SUSPENSION OF SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA AND LUPRON DEPOT (LEUPROLIDE ACETATE) 7.5 MG DEPOT SUSPENSION OF TAPPHARMACEUTICAL INC., LAKE FOREST, IL 60045, USA, UNDER FASTING CONDITIONS, IN 60 PROSTATIC CARCINOMA PATIENTS UNDERGOING INITIAL THERAPY.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- 1) To characterize the rate and extent of bioavailability of the test products in comparison with the reference product after single dose administration under fasting conditions,
研究概览
简要总结
This study is a randomized, multi center, open label, two treatment, two period, two sequence, single dose, crossover study for monitoring the safety of the subjects participating in the study and to assess the bioequivalence of Leuprolide Acetate 7.5 mg Depot suspension of Sun Pharmaceutical Industries Limited, India and Lupron Depot (Leuprolide Acetate) 7.5 mg depot Suspension of TAP Pharmaceutical Inc., Lake Forest, IL 60045, USA, under fasting conditions in 60 Prostatic carcinoma patients undergoing initial therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Volunteers meeting all of the following criteria will be considered for enrollment in the study: i.
- •Availability of volunteer for the entire study period and willingness to adhere to protocol requirements.
- •Prostatic carcinoma patients undergoing initial therapy, at least 18-years of age or older, subject’s body mass index (BMI) must be within 18.5 – 30.0 (Kg/m2).
- •Subjects who have no evidence of underlying disease (Except Prostatic carcinoma) during screening medical history and whose physical examination is performed within 28 days prior to commencement of the study.
- •Patients whose life expectancy of greater than or equal to 6 months.
- •Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance.
排除标准
- •History or presence of significant: i.
- •Allergy or Significant history of hypersensitivity to Leuprolide and/or any of the excipients in Leuprolide depot and GnRH, GnRH agonist analogs.
- •Evidence of severe renal, hepatic, cardiovascular or psychiatric illness.
- •Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- •Smoking or consumption of tobacco products.
- •Difficulty in coming for follow up.
- •Clinically significant illness (except defined in section 6.4 ii) within 4 weeks before the start of the study vii.
- •Positive result to HIV, HCV, RPR and HBsAg. viii.
- •Abnormal 12 lead ECG, X-ray.
- •Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study
- •Participation in another clinical trial within the preceding 90 days of study starts.
- •Subjects who have: i.
- •Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg ii.
- •Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the Investigator.
- •Pulse rate below 60/min.
- •or above 100/min.
结局指标
主要结局
1) To characterize the rate and extent of bioavailability of the test products in comparison with the reference product after single dose administration under fasting conditions,
时间窗: Pre-dose blood sample: 10 ml will be collected within a period of 15 minute before dosing. | Post dose sample :0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.0, 72.0, 168.0, 360.0, 504.0 and 672.0 hours post dosing (1 x 3 ml each) in plain vacutainers in each period. | Note:The 672.00hr post dose sampling for period I will be consider as the predose blood samples for period.
2) Monitor the safety of the subjects participating in the study and the tolerability of the test products in comparison with the reference considering adverse events.
时间窗: Pre-dose blood sample: 10 ml will be collected within a period of 15 minute before dosing. | Post dose sample :0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.0, 72.0, 168.0, 360.0, 504.0 and 672.0 hours post dosing (1 x 3 ml each) in plain vacutainers in each period. | Note:The 672.00hr post dose sampling for period I will be consider as the predose blood samples for period.
次要结局
- NA(NA)