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临床试验/CTRI/2019/08/020820
CTRI/2019/08/020820Other不适用

A randomized, open label, multi-center, two-treatment, single-period, parallel group, single dose, Pharmacokinetic - Pharmacodynamic study of Leuprorelin Acetate Injectable Suspension 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea with Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, Japan in male subjects with metastatic prostate cancer undergoing initial therapy under fasting condition

Daewoong Pharmaceutical Co Ltd6 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月15日最近更新:
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试验速览

阶段
不适用
状态
Other
发起方
入组人数
20
试验地点
6
主要终点
To establish PK and PD bioequivalence of Luphere (Leuprorelin Acetate) depot Injection 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea and Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, Japan
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The Study is A randomized, open label, multi-center, two-treatment, single-period, parallel group, single dose, Pharmacokinetic - Pharmacodynamic study of Leuprorelin Acetate Injectable Suspension 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea with Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, Japan in male subjects with metastatic prostate cancer undergoing initial therapy under fasting condition Primary Objective: To establish PK and PD bioequivalence of Luphere (Leuprorelin Acetate) depot Injection 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea and Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, Japan Secondary Objective: Safety and tolerability of test product compared to reference product by monitoring adverse events

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)（—）
性别
Male

入选标准

  • •Subjects must be able to provide voluntary written informed consent and to follow protocol requirements
  • •Male subjects aged 18 to 75 years (both inclusive) having Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m
  • •Subjects with histologically/cytologically confirmed prostate cancer.
  • •Newly diagnosed metastatic prostate cancer patients scheduled to receive their first dose of leuprorelin acetate as a part of their standard of care.
  • •Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Refer appendix A).
  • •Acceptable hematology status: a.
  • •Hemoglobin ≥ 9 g/dL b.
  • •Absolute neutrophil count (ANC) ≥ 1500 cells/μL c.
  • •Platelet count ≥ 75,000 cells/μLprior to dosing.
  • •Acceptable liver function: a.
  • •Alanine aminotransferase (ALT) ≤ 2X upper limit of normal (ULN) b.
  • •Aspartate aminotransferase (AST) ≤ 2X ULN c.
  • •Bilirubin < 1.2 mg/dL d.
  • •Alkaline phosphatase ≤ 5X ULN
  • •Subjects with creatinine clearance ≥ 60 mL/minute.
  • •Subjects with HbA1c ≤ 7 %.
  • •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
  • •Subjects who agree to use adequate male contraceptive methods while in the study
  • •Subjects with life expectancy of > 180 days at the time of screening.

排除标准

  • •Known hypersensitivity or contraindication to GnRH, GnRH agonist or to any of the components of investigational product.
  • •History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
  • •Prior orchidectomy, hypophysectomy or adrenalectomy
  • •Clinical indication of urinary tract obstruction
  • •Subjects with major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
  • •Subjects with surgical or other non-healing wounds
  • •Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
  • •Subjects with positive urine screen for drugs of abuse.
  • •Subjects with positive alcohol breath test.
  • •Smokers who smoke greater than or equal to 10 cigarettes or equivalent per day
  • •Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
  • •Donation of ≥ 350 mL blood within 90 days prior to receiving the first dose of investigational product for the current study.
  • •Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
  • •Any other condition(s) which could significantly interfere with Protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.
  • •Subjects with known CNS metastasis
  • •Subjects with history of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).

结局指标

主要结局

To establish PK and PD bioequivalence of Luphere (Leuprorelin Acetate) depot Injection 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea and Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, Japan

时间窗: Day01: Pre-dose blood sample (00.00) within 30 minutes prior to dosing. 00.25 hr, 00.50 hr. 01.00 hr. 01.50 hr, 02.00 hr. 02.50 hr. (± 05 minutes), 03.00 hrs, 04.00 hr, 06.00 hr, 08.00 hr, 12.00 hr (± 10 minutes), Day02: 24.00 hr (± 10 minutes), Day03: 48.00 hr, Day07:144.00 hr, Day14: 312.00 hr, Day21: 480.00 hr, Day28: 648.00 hr, Day35: 816.00 hr(± 4 hr), Day42: 984.00 hr, Day56: 1320.00 hr, Day 70 1656.00 hr, Day84: 1992.00 hr, Day98: 2328.00 hr, Day112: 2664.00 hr (± 1 Day)

次要结局

  • Safety and tolerability of test product compared to reference product by monitoring adverse events(Day01: Pre-dose blood sample (00.00) within 30 minutes prior to dosing. 00.25 hr, 00.50 hr. 01.00 hr. 01.50 hr, 02.00 hr. 02.50 hr. (± 05 minutes), 03.00 hrs, 04.00 hr, 06.00 hr, 08.00 hr, 12.00 hr (± 10 minutes), Day02: 24.00 hr (± 10 minutes), Day03: 48.00 hr, Day07:144.00 hr, Day14: 312.00 hr, Day21: 480.00 hr, Day28: 648.00 hr, Day35: 816.00 hr(± 4 hr), Day42: 984.00 hr, Day56: 1320.00 hr, Day 70 1656.00 hr, Day84: 1992.00 hr, Day98: 2328.00 hr, Day112: 2664.00 hr (± 1 Day))

研究者

发起方
Daewoong Pharmaceutical Co Ltd
申办方类型
Pharmaceutical industry-Global

研究点 (6)

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