CTRI/2020/10/028441已完成4 期
A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-way cross-over, multiple dose, steady-state Bioequivalence (BE) study of Pazopanib HCl 200mg Tablets at a dose of 800 mg (4 x 200 mg tablets) of Torrent Pharmaceuticals Ltd., India with VOTRIENT® (Pazopanib HCl 200mg) Tablets at a dose of 800 mg (4 x 200 mg tablets) of Novartis Pharmaceuticals Corporation, USA in subjects with Advanced renal cell carcinoma under fasting condition.
Torrent Pharmaceuticals Ltd India23 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年11月25日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 23
- 主要终点
- To assess the bioequivalence and characterize the pharmacokinetic profiles of Pazopanib HCl 200mg Tablets of Torrent Pharmaceuticals Ltd., India compared to VOTRIENT® (Pazopanib HCl 200 mg) Tablets of Novartis Pharmaceuticals Corporation.
研究概览
简要总结
This study is arandomized, open label, multi-center, two-treatment, two-period, two-sequence,two-way cross-over, multiple dose, steady-state Bioequivalence (BE) study ofPazopanib HCl 200mg Tablets at a dose of 800 mg (4 * 200 mg tablets) of TorrentPharmaceuticals Ltd., India with VOTRIENT® (Pazopanib HCl 200mg) Tablets at adose of 800 mg (4 * 200 mg tablets) of Novartis Pharmaceuticals Corporation,USA in subjects with Advanced renal cell carcinoma under fasting condition.
The primaryobjective of this is to evaluate bioequivalence of Pazopanib HCl 200mg Tabletsof Torrent Pharmaceuticals Ltd., India compared to VOTRIENT® (Pazopanib HCl200mg) Tablets of Novartis Pharmaceuticals Corporation, in subjects withAdvanced renal cell carcinoma under fasting condition.
"This syudy will be managed by CBCC Global research in agreement with sponsor (Torrent Pharmaceuticals Ltd., India)"
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
- All
入选标准
- •Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- •Subjects aged greater than 18 years having Body Mass Index at least 17.00 calculated as weight in kg per height in m
- •Subjects with confirmed diagnosis of advanced renal cell carcinoma, already receiving stable dose of Pazopanib HCl tablets of 800 mg per day since at least last 4 weeks.
- •Subjects able to swallow and retain oral medication
- •Life expectancy of at least 3 months at the time of enrolment.
- •Acceptable hematology status: a.
- •Hemoglobingreater than or equal to9.0 g per dL b.
- •Absolute neutrophil count greater than or equal to1500 cells per mm3 c.
- •Platelet count greater than or equal to 1,00,000 cells per mm3
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) less than or equal to 2 X ULN b.
- •Bilirubin less than or equal to ULN d.
- •Alkaline phosphatase less than or equal to 5 X ULN
- •Subjects with Creatinine clearance greater than or equal to 60 mL per minute
- •Cardiac ejection fraction greater than or equal to 50 Percentage by echocardiogram within 28 days of first dose of Investigational Product.
- •Male subjects (including those who had a vasectomy) with female partners of reproductive potential must agree to use condoms from screening, during study and for at least two weeks after treatment discontinuation.
- •Female subjects with negative serum pregnancy test at screening and at Day
- •Women of childbearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing acceptable methods of contraception during study and for at least two weeks after treatment discontinuation.
- •Acceptable methods of contraception are: a.
- •Oral or other (e.g. injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication b.
- •Intrauterine device IUD or intrauterine system IUD or IUS c.
- •Double barrier method of contraception Condom and occlusive cap or condom and spermicidal agent d.
- •Male sterilization at least 6 months prior to the screening, should be the sole male partner for that subject e.
- •Female sterilization surgical bilateral oophorectomy or tubal ligation at least 6 weeks prior to study participation f.
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •Known hypersensitivity to Pazopanib or the components of investigational product.
- •History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •Subjects with hypokalemia, hypomagnesaemia, long QT syndrome (QTc of >450 msec in male or QTc of > 470 msec in female) or history of cardiac disease at the time of screening
- •Subjects found with major vascular disease or VTE in previous 6 months from the screening
- •Currently receiving or anticipated to receive any medications or substances that are strong inhibitors or inducers of the CYP3A4 and CYP450 inducer or inhibitor; narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2D6 or CYP2C8; simvastatin, H2 receptor antagonist and PPIs. (Appendix B)
- •If subjects are on anti-coagulant therapy during study participation
- •Receiving any drugs known to prolong the QT interval within 4 weeks prior to study or during the study
- •Known CNS metastasis.
- •History or presence of Thrombotic microangiopathy (TMA) or any other dermatological toxicity.
- •Subjects with ECOG Performance Status of >
- •Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •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 current clinical or laboratory evidence of active infection.
- •History of other malignancies in the last 5 years
- •Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable), Hemoglobin greater than or equal to 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (As per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
- •If subjects found positive in urine screen for drugs of abuse
- •Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •Loss of greater than or equal to 350mL (1 unit) of blood within 90 days before enrollment in the study.
- •Lactating women.
结局指标
主要结局
To assess the bioequivalence and characterize the pharmacokinetic profiles of Pazopanib HCl 200mg Tablets of Torrent Pharmaceuticals Ltd., India compared to VOTRIENT® (Pazopanib HCl 200 mg) Tablets of Novartis Pharmaceuticals Corporation.
时间窗: A total of twenty six (26) blood PK blood samples of 3.0 mL from each subject will be collected during the study duration. Sample 1:Day 26&34-Pre-dose blood sample (-48.00) hours,Sample 2: Day 17&35-Pre-dose blood sample (0.00) hours(within 5 minutes prior to dosing),Sample 3to12: Pre-dose blood sample (0.00) hours,0.50hrs, 1.00hrs,02.00hrs,03.00hrs,04.00hrs,05.00hrs,06.00hrs,08.00hrs,12.00hrs(± 05 minutes),Sample 13:Day19&37-24.00 hours(Within 5 minutes prior to next dose of IP administration)
次要结局
- To assess the safety of Pazopanib HCl 200mg Tablets of Torrent Pharmaceuticals Ltd., India in subjects with Advanced Renal cell Carcinoma.(A total of twenty six (26) blood PK blood samples of 3.0 mL from each subject will be collected during the study duration. Sample 1:Day 26&34-Pre-dose blood sample (-48.00) hours,Sample 2: Day 17&35-Pre-dose blood sample (0.00) hours(within 5 minutes prior to dosing),Sample 3to12: Pre-dose blood sample (0.00) hours,0.50hrs, 1.00hrs,02.00hrs,03.00hrs,04.00hrs,05.00hrs,06.00hrs,08.00hrs,12.00hrs(± 05 minutes),Sample 13:Day19&37-24.00 hours(Within 5 minutes prior to next dose of IP administration))
研究者
研究点 (23)
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