To monitor the safety and to assess the bioequivalence of Temozolomide 250 mg capsule of Sun Pharmaceutical Industries Ltd. and Temodal (Temozolomide) 250mg capsule of Merck Canada Inc. in cancer patients with high grade glioma, under fasting conditions.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Patients with High Grade Glioma under fasting condition

• Registration Number: CTRI/2014/05/004644
• Lead Sponsor: Sun Pharmaceutical Industries Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

i. Patients between 18-55 years of age.

ii.Patients with high grade glioma who are already receiving or are about to start receiving temozolomide 250 mg dose once daily.

iii.Patients with Performance more than equal to 2 on the ECOG performance scale (listed in Appendix III).

iv.Subjects who have no evidence of underlying disease which in the judgment of the investigator would not make the subject inappropriate for getting enrolled in the study (Except high grade glioma) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.

v.Subject willing to give written consent according to section 16.3 of the protocol.

vi.Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance.

vii.Patients whose life expectancy of greater than or equal to 6 months.

viii.Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

ix.Female Subject

•of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or sexual abstinence.

OR

•Postmenopausal for at least past 12 months.

OR

•surgically sterile (bilateral tubal ligation / bilateral oophorectomy / hysterectomy has been performed on the subject)

Exclusion Criteria

i.Subject with a history of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease in the last 12 months.

ii.Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any drug or excipients.

iii.Use of Valproic Acid as concurrent therapy.

iv.Subjects determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results. (e.g. history of surgery of the gastro-intestinal tract, which may interfere with absorption, except for appendectomy).

v.Clinically significant illness (except high grade glioma) within 4 weeks before the start of the study

vi.Patients taking chemotherapeutic agent except temozolomide.

vii.Female subject who is pregnant, lactating or likely to become pregnant or have a positive pregnancy test at screening or prior to check in.

viii.Subjects with a history of alcohol, drug or substance abuse in the past 12 months.

ix.Subjects who have used enzyme inducing or inhibiting drugs (Griseofulvin etc.) within 30 days of Period 1 dosing.

x.Subjects deemed uncooperative or noncompliant.

xi.Smoking or consumption of tobacco products.

xii.Subjects who have participated in any clinical trial within the last 90 days prior to Period 1 dosing.

xiii.Blood donation within 90 days prior to first dosing.

xiv.Subjects who have:

Systolic blood pressure <90 mm of Hg or >140 mm of Hg

Diastolic blood pressure <60 mm of Hg or >90 mm of Hg

Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.

Radial pulse rate <60/min. or >100/min.

xv.Patients shall be excluded for any of the following laboratory results:

a. Patients with Absolute neutrophil counts (ANC) < 1500 cells/μL.

b. Patients with platelet counts < 100,000/ μL.

ï?­However, If ANC and platelet counts remain below these levels, at the discretion of the investigator, the patient can be enrolled in the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified