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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103322
• Other study ID #: ARL/CT/13/001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 1, 2014
• Last updated: June 25, 2014
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Amneal Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Srinivasam Cancer Care Hospitals India Pvt.	Bangalore	Karnataka
India	Karnataka Caner Hospital	Bengaluru	Karnataka
India	Lokmaya Hospital	Pune	Maharashtra
India	Dr. G Viswanathan Speciality Hospitals	Tiruchirappalli	Tamil Nadu
India	Kailash Cancer Hospital & Research Centre	Vadodara	Gujurat

Sponsors (2)

Lead Sponsor	Collaborator
Amneal Pharmaceuticals, LLC	Accutest Research Laboratories (I) Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Peak maximum concentration over dosing interval in the steady state	Days 5, 6, 7, 12, 13, 14 and 15	No
Primary	AUC0-tau	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	Days 5, 6, 7, 12, 13, 14 and 15	No
Secondary	Tmax	The time to reach such peak over dosing interval in the steady state	Days 5, 6, 7, 12, 13, 14 and 15	No
Secondary	Cmin	Minimum concentration established at each dose interval end of the steady state	Days 5, 6, 7, 12, 13, 14 and 15	No
Secondary	Cavg	Average concentration in the steady state (= AUC0-tau / tau)	Days 5, 6, 7, 12, 13, 14 and 15	No
Secondary	Swing	Swing in steady state pharmacokinetics, calculated as (CmaxSS-CminSS)/ CminSS	Days 5, 6, 7, 12, 13, 14 and 15	No
Secondary	Fluctuation Rate	Degree of fluctuation in the steady state pharmacokinetics, calculated as (Cmax-Cmin)/CavSS	Days 5, 6, 7, 12, 13, 14 and 15	No