Bioequivalence study of imatinib mesylate tablets in patients of chronic myeloid leukemia and gastrointestinal stromal tumor

Not Applicable

Completed

Conditions: Health Condition 1: null- Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumor

Registration Number: CTRI/2014/02/004385

Lead Sponsor: Amneal Pharmaceuticals LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

2. Diagnosed case of Philadelphia chromosome positive (Ph+) CML or GIST and presently being treated with imatinib 400 mg tablets.

3. Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.

4. Female patients of child bearing potential (except for those who have completed one year since menopause or have been hysterectomized) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing and must agree to use effective contraception (barrier or hormonal) for the study period.

Exclusion Criteria

The Patients with any of the following criteria should be excluded.

1. History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.

2. Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase

3. Abnormal laboratory results as below,

• Absolute neutrophils count less than 1000/ mm3

• Platelet Count less than 50,000/mm3

• SGOT and/or SGPT greater than 5 times upper limit of normal (ULN)

• Serum total Bilirubin greater than 3 times ULN

• Serum TSH greater than 10 microIU/mL

• Serum Uric Acid greater than 12 mg/dL

• Reactive for HIV antibody, HBsAg or HCV antibody

4. History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).

5. History of therapy with any of the following as per timelines before randomization,

• Inducers of CYP3A4 activity within 14 days

• Inhibitors of CYP3A4 activity within 14 days.

• Investigational product/ device within last one month

6. Alcohol or any drug dependence within past one year.

7. Blood donation/ loss exceeding 200 ml within last 60 days.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess biequivalence of intervention product compared to comparator product at steady state pharmacokinetics under fed conditionsTimepoint: Blood sampling will be done from predose to untill 24 hours after the dosing on day 7 and day 14 of the study

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of intervention product compared to comparator product by adverse eventsTimepoint: Throughout the study from dosing till follow up on day 22