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Imatinib Mesylate Tablets, 400 mg. Once daily for 14 days.

Brown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side.

Imatinib Mesylate Tablets, 400 mg

Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with "400" on one side with score on the other side, and "SL" on each side of the score.

Ashutosh Jani, MD

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.

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.

Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions

A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA With GLEEVEC® (Imatinib Mesylate) Tablets 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions

Peak maximum concentration over dosing interval in the steady state

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

The time to reach such peak over dosing interval in the steady state

Minimum concentration established at each dose interval end of the steady state

Average concentration in the steady state (= AUC0-tau / tau)

Swing in steady state pharmacokinetics, calculated as (CmaxSS-CminSS)/ CminSS

Degree of fluctuation in the steady state pharmacokinetics, calculated as (Cmax-Cmin)/CavSS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions	NCT02103322	Chronic Myeloid... Gastrointestina...	Imatinib Mesyla... Imatinib Mesyla...	18 Years - 55 Years	Amneal Pharmaceuticals, LLC
Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions	NCT02103322	Chronic Myeloid... Gastrointestina...	Imatinib Mesyla... Imatinib Mesyla...	18 Years - 55 Years	Amneal Pharmaceuticals, LLC
Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions	NCT02103322	Chronic Myeloid... Gastrointestina...	Imatinib Mesyla... Imatinib Mesyla...	18 Years - 55 Years	Amneal Pharmaceuticals, LLC

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