A study to monitor the safety and to assess thesteady-state bioequivalence of Imatinib Mesylate 400 mg tablets of SunPharmaceutical Industries Ltd, India in Chronic Myeloid Leukemia (CML) patients

Not Applicable

Completed

Conditions: Health Condition 1: null- CHRONIC MYELOID LEUKEMIA (CML)

Registration Number: CTRI/2014/03/004484

Lead Sponsor: Sun Pharmaceutical Industries Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

i. Availability of subject for the entire study period and willingness to adhere to protocol

requirements.

ii. Patients between 18 to 60 years of age.

iii. Patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia

(Ph+ CML) in chronic phase

iv. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in

chronic phase after failure of interferon-alpha therapy.

v. Subjects with Performance <= 2 on the ECOG performance scale (listed in Appendix III).

vi. 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

CML) during screening, medical history and whose physical examination is performed within

21 days prior to commencement of the study.

vii. Subjects whose screening laboratory values are within normal limits or considered by the

Investigator/sub-Investigator to be of no clinical significance.

viii. Informed consent form given in written form according to section 9.3 of the protocol.

ix. Female Subjects

• 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 abstinence.

• Postmenopausal for at least 1 year.

• surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has

been performed on the subject)

Exclusion Criteria

1. History or presence of significant:

•Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Imatinib Mesylate

and/or any related compounds etc.

•Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,

dermatologic, musculoskeletal, neurological or psychiatric disease which has an impact on

subject safety and does not permit dosing of imatinib.

•Use of following drugs as concurrent therapy:

Erythromycin, warfarin, CYP inhibitors (e.g. ketoconazole, itraconazole, clarithromycin,

atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin,

voriconazole) or CYP inducers (e.g. dexamethasone, phenytoin, carbamazepine,

oxcarbazepine, rifampicin, rifabutin, Rifampin, phenobarbital, fosphenytoin, primidone or

Hypericum perforatum, also known as St. Johns Wort, Griseofulvin).

•Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within

past one year.

•Smoking (>= 10 cigarettes/day) or consumption of tobacco products (>= 4 chews/day).

•History of difficulty in swallowing or coming for follow up.

•Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks

preceding the study

•Female subject who is pregnant, lactating or likely to become pregnant or have a positive

pregnancy test at screening and prior to study.

•Positive result to HIV, HCV, RPR and HBsAg.

•Abnormal 12 lead ECG, X-ray.

2 Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study

3 Participation in another clinical trial within the preceding 90 days of study starts.

4 Subjects who have:

•Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg

•Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor

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

•Pulse rate below 60/min. or above 100/min.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To monitor the safety of the subjects participating in the study and to assess the <br/ ><br>steady-state bioequivalence of Imatinib Mesylate 400 mg tablets of Sun <br/ ><br>Pharmaceutical Industries Ltd, India and Gleevec (Imatinib Mesylate) 400 mg <br/ ><br>Tablets of Novartis Pharmaceuticals Corporation under fed condition.Timepoint: From Day-0 to Day-31.

Secondary Outcome Measures