Comparision of two Temozolomide 250 mg capsules in the patients with Glioblastoma Multiforme or Anaplastic Astrocytoma under fasting condition.

Not Applicable

Completed

Conditions: Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Registration Number: CTRI/2012/09/002951

Lead Sponsor: Fresenius Kabi Oncology Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1.Signed written informed consent for participation in the trial. 2. Recovered from any toxic effects of previous chemotherapy as judged by the Investigator.3. Having a Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2. 4. Patients with a life expectancy of at least three months. 5. Patient with adequate bone marrow, renal and hepatic function. 6. Able to comply with study requirement in opinion of Principal Investigator

Exclusion Criteria

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.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic profile of the sponsorâ??s test formulation (Temozolomide 250 mg capsules) relative to that of reference formulation <br/ ><br>(TEMODALÂ® 250 mg capsules) in adult, male or female, patients under fasting conditions and to assess the bioequivalence <br/ ><br>Timepoint: The venous blood samples will be withdrawn Pre-dose and 0.16 (10 min), 0.25 <br/ ><br>(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 <br/ ><br>administration.

Secondary Outcome Measures