Healthy volunteers (Chronic Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Myelodysplastic/myeloproliferative diseases, advanced hypereosinophilic syndrome and/or chronic eosinophilic leukaemia) MedDRA version: 20.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Imatinib Powder for oral solution 800 mg/10 ml
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Concentration unit: mg/ml mi
Sponsors
Intas Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Non-smoker, normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive). b. Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg / height in m2. c. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings. d. Able to understand and comply with the study procedures, in the opinion of the investigator. e. Able to give voluntary written informed consent for participation in the trial. f. In case of female subjects: i. Surgically sterilized at least 6 months prior to study participation. Or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. And ii. Serum pregnancy test must be negative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i. Known hypersensitivity or idiosyncratic reaction to Imatinib or to any of its excipients or any drug or any substance. ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal disorder including bleeding or any other body system disorders. iii. Ingestion or use of any medication (including herbal remedies, inhibitors and/or inducers of CYP3A4 family) at any time in 14 days prior to dosing of period I. In any such case subject selection will be at the discretion of the Principal Investigator. iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. v. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 % distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine in period I. vi. Smokers, or who have smoked within last six months prior to start of the study. vii. The presence of clinically significant abnormal laboratory values during screening. viii. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. ix. History or presence of seizure or psychiatric disorders. x. A history of difficulty with donating blood. xi. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication. xii. Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**. ** If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received. xiii. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. xiv. A positive test result for HIV (1 &/or 2) antibody. xv. Consumption of Grapefruits or its products within a period of 72 hours prior to receiving the study drug in period I. xvi. Difficulty in swallowing solids dosage forms like tablets or capsules xvii. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator. xviii. Nursing mothers (females)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the bioavailability and characterize the pharmacokinetic profile of the sponsors test product with reference product in normal, healthy, adult, human subjects under fasting condition;Secondary Objective: To monitor the adverse events and to ensure the safety of the subjects. To evaluate taste/palatability of the sponsor’s test product in order to assess overall subjects compliance;Primary end point(s): To compare the bioavailability and characterize the pharmacokinetic profile of the sponsors test product with reference product in normal, healthy, adult, human subjects under fasting condition;Timepoint(s) of evaluation of this end point: A total of 25 blood samples, each of 04 mL will be collected from each subject in each period. The venous blood samples will be withdrawn at pre dose (0.000 hour) and at 0.250, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours post dose following drug administration in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To monitor the adverse events and to ensure the safety of the subjects. To evaluate taste/palatability of the sponsor’s test product in order to assess overall subjects compliance;Timepoint(s) of evaluation of this end point: Clinical examination- screening, after check-in, before checkout and at the end of the study. Laboratory assessment- at the time of screening and hematology & biochemistry- prior to period-II. Subjects will be questioned for wellbeing at the time of clinical examinations, during ambulatory sample and during recording of vital signs in each study period. Vitals Sitting blood pressure and radial pulse - prior to dosing and at 1, 3, 6, 11, 24 and 36 hrs after dosing in each period. Chest X-ray (during the last 6 months) and 12-Lead ECG - during screening. Subjects will be informed to refrain from driving or operating machinery during the study Subject will be instructed not to participate in other clinical trial or donate blood anywhere else during the study. | — |
Countries
India
Contacts
Public ContactMr. Kavan Pandya
Intas Pharmaceuticals Ltd.
Outcome results
None listed