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Megavec 400 mg (Imatinib Mesylate) in Healthy Adult Male Volunteers

NCT ID: NCT01653314

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Megavec

Group Type EXPERIMENTAL

Megavec

Intervention Type DRUG

Glivec

Intervention Type DRUG

Glivec

Group Type ACTIVE_COMPARATOR

Megavec

Intervention Type DRUG

Glivec

Intervention Type DRUG

Interventions

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Megavec

Intervention Type DRUG

Glivec

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy and male subjects aged 20 to 55 years
* The subject has a Body weight ≥55 kg and ideal body weight (IBW) within ±20%
* A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
* A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.

Exclusion Criteria

* A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, hematology, neurology and psychology function or other significant diseases and history
* Known allergy or hypersensitivity to the study medication
* AST or ALT greater than 1.25 times the upper limit of reference range or Total bilirubin greater than 1.25 times the upper limit of reference range base on screening results
* A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW_MGV001

Identifier Type: -

Identifier Source: org_study_id