Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
Conditions
Brief summary
To characterize pharmacokinetic profile of test product compared to that of the corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor under Fed Conditions.
Detailed description
To characterize pharmacokinetic profile of Imatinib Mesylate tablets EQ 400 mg base of Amneal Pharmaceuticals LLC, compared to that of the reference product - GLEEVEC® (imatinib mesylate) tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.
Interventions
DRUGImatinib Mesylate Tablets, 400 mg
Brown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side.
Sponsors
Accutest Research Laboratories (I) Pvt. Ltd.
Amneal Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 55 years (both inclusive) and either sex * Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets. * Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements. * Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.
Exclusion criteria
* History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator. * Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase * Abnormal laboratory results as below: * History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM). * History of therapy with any of the following as per timelines before randomization: inducers of CYP3A4 activity and inhibitors of CYP3A4 activity, within 14 days, investigational product/device within last one month * Alcohol or any drug dependence within past one year. * Blood donation/loss exceeding 200 ml within last 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Days 5, 6, 7, 12, 13, 14 and 15 | Peak maximum concentration over dosing interval in the steady state |
| AUC0-tau | Days 5, 6, 7, 12, 13, 14 and 15 | The area under the blood concentration curve versus time, calculated by the trapezoid method, from zero time to the dose interval (tau) in the steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cavg | Days 5, 6, 7, 12, 13, 14 and 15 | Average concentration in the steady state (= AUC0-tau / tau) |
| Tmax | Days 5, 6, 7, 12, 13, 14 and 15 | The time to reach such peak over dosing interval in the steady state |
| Fluctuation Rate | Days 5, 6, 7, 12, 13, 14 and 15 | Degree of fluctuation in the steady state pharmacokinetics, calculated as (Cmax-Cmin)/CavSS |
| Swing | Days 5, 6, 7, 12, 13, 14 and 15 | Swing in steady state pharmacokinetics, calculated as (CmaxSS-CminSS)/ CminSS |
| Cmin | Days 5, 6, 7, 12, 13, 14 and 15 | Minimum concentration established at each dose interval end of the steady state |
Countries
India
Outcome results
None listed