A multicentre, randomized,open label,two-period, two-treatment,two-way crossover, bioequivalence study comparing Temozolomide capsules 250 mg (Manufactured by: Fresenius Kabi Oncology Limited, India) to the reference listed drug Temodal® (Temozolomide) Capsules 250 mg (Manufactured by: Orion Corporation, Orion Pharma Division, Turku, Finland, Distributed by Schering-Plough Products Pharmaceuticals Ltd.,Brazil) in Glioblastoma Multiforme or Anaplastic Astrocytoma patients under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- To characterize the pharmacokinetic profile of the sponsor’s test formulation (Temozolomide 250 mg capsules) relative to that of reference formulation
研究概览
简要总结
| Temozolomide is an imidazotetrazine-alkylating agent with antitumor activity. At physiological pH the drug get metabolized to monomethyl triazeno imidazole carboxamide (MTIC). MTIC shows cytotoxicity due to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position. |
This study is being conducted to compare & characterize the relative bioavailability & pharmacokinetic profile of the Sponsor’s formulation (Temozolomide capsule 250 mg) with respect to the reference formulation (Temodal® (Temozolomide) capsules 250 mg) in single oral dose to adult patients with Glioblastoma Multiforme or Anaplastic Astrocytoma under fasting condition,who in the opinion of their treating physicians are candidates for the Temozolomide therapy.
Temozolomide is a cytotoxic drug; hence the study cannot be conducted on the healthy volunteer.
The primary objective of the study is to characterize the pharmacokinetic profile of the sponsor’s test formulation to that of reference formulation & secondary objective is to monitor the safety of the patients.
Bioequivalence will be concluded if the 90% confidence intervals for ln-transformed pharmacokinetic parameters Cmax and AUC0-t fall within the acceptance range of 0.8 – 1.25 for Temozolomide.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Signed written informed consent for participation in the trial.
- •Recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
- •Having a Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m
- •Patients with a life expectancy of at least three months.
- •Patient with adequate bone marrow, renal and hepatic function.
- •Able to comply with study requirement in opinion of Principal Investigator.
排除标准
- •1.Known hypersensitivity to Temozolomide, Dacarbazine or any other ingredients of the formulation 2.Use of any chemotherapy drugs within 21 days prior to dosing 3.History of drug/alcohol addiction 4.History of smoking or tobacco chewing in last 3 months 5.Known Galactose intolerant, known deficiency of the Lapp lactase or glucose-galactose malabsorption 6.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies or positive VDRL test 7.Patients with HIV infection.
- •8.Positive for Drug of abuse test and alcohol screen test 9.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
结局指标
主要结局
To characterize the pharmacokinetic profile of the sponsor’s test formulation (Temozolomide 250 mg capsules) relative to that of reference formulation
时间窗: The venous blood samples will be withdrawn Pre-dose and 0.16 (10 min), 0.25 | (15 min), 0.33 (20 min) 0.50 (30 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50,3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each period | administration.
(TEMODAL® 250 mg capsules) in adult, male or female, patients under fasting conditions and to assess the bioequivalence
时间窗: The venous blood samples will be withdrawn Pre-dose and 0.16 (10 min), 0.25 | (15 min), 0.33 (20 min) 0.50 (30 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50,3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each period | administration.
次要结局
- To monitor the safety of the patients exposed to the Investigational Medicinal Product(NIL)