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

NCT02103322 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-27

No results posted yet for this study

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.

Conditions

  • Chronic Myeloid Leukemia
  • Gastrointestinal 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.

Sponsors & Collaborators

  • Accutest Research Laboratories (I) Pvt. Ltd.

    collaborator INDUSTRY

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Ashutosh Jani, MD · Accutest Research Laboratories (I) Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103322 on ClinicalTrials.gov