MedTrace Logo

A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)

NCT01751919 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2014-10-01

No results posted yet for this study

Summary

1. Investigational Product

1. Imatinib mesylate tablet 400 mg
2. Glivec film-coated tablet 100 mg (Comparator)
2. Expected target disease

1. chronic myeloid leukemia
2. Gastrointestinal stromal tumors
3. Study design : Randomized, open-label, single dose, two-period, two-way, crossover study

1. 36 healthy subjects, 2 groups (18 subjects/group)
2. 2 Period (either 1-a(1 tablet) or 1-b(4 tablet))
3. wash-out period : 14 days
4. Evaluation on pharmacokinetics(PKs) and safety

1. PKs : Cmax, AUClast, Tmax, AUCinf, t1/2
2. safety : adverse events, physical examination, vital sign, ECG, Laboratory test
5. Statistical method

1. Demography Characteristics
2. Pharmacokinetic parameters
3. Safety data

Conditions

  • Chronic Myeloid Leukemia
  • Gastrointestinal Stromal Tumor

Interventions

DRUG

Imatinib mesylate tablet 400 mg, 1 Tablet

DRUG

Glivec film-coated tablet 100 mg, 4 Tablets

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT01751919 on ClinicalTrials.gov