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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/09/002951
Enrollment
40
Registered
2012-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Temozolomide capsule 250 mg: One capsule of 250 mg of Temozolomide (Test or Reference) will be administered to the patients in each period. The period I and period II will be the day 1

Sponsors

Fresenius Kabi Oncology Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To characterize the pharmacokinetic profile of the sponsorâ??s test formulation (Temozolomide 250 mg capsules) relative to that of reference formulation (TEMODAL® 250 mg capsules) in adult, male or female, patients under fasting conditions and to assess the bioequivalence Timepoint: 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.—

Secondary

MeasureTime frame
To monitor the safety of the patients exposed to the Investigational Medicinal ProductTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Praveen Shetty

Lambda Therapeutic Research Ltd.

ankitranpura@lambda-cro.com07940202074

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026