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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

March 31, 2014

Study Completion Date

June 30, 2014

Conditions
Chronic Myeloid LeukemiaGastrointestinal Stromal Tumor
Interventions
DRUG

Imatinib Mesylate Tablets, 400 mg

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

DRUG

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."

Trial Locations (5)

391760

Kailash Cancer Hospital & Research Centre, Vadodara

411044

Lokmaya Hospital, Pune

560076

Srinivasam Cancer Care Hospitals India Pvt., Bangalore

560096

Karnataka Caner Hospital, Bengaluru

620 008

Dr. G Viswanathan Speciality Hospitals, Tiruchirappalli

Sponsors
All Listed Sponsors
collaborator

Accutest Research Laboratories (I) Pvt. Ltd.

INDUSTRY

lead

Amneal Pharmaceuticals, LLC

INDUSTRY

NCT02103322 - Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions | Biotech Hunter | Biotech Hunter