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CompletedNCT01795716Updated May 19, 2015Results posted

Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

A Phase 1 interventional study of mesylate imatinib capsule and Glivec in Chronic Myeloid Leukemia, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-05-19.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

  1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG).
  2. Experimental Design： Two-period crossover design
  3. Test drug: imatinib mesylate capsule Reference drug: Glivec
  4. Sample size：20
Read the detailed description

To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG) and compare the bioequivalence and pharmacokinetics of the two products in 20 patients with chronic myeloid leukemia.

02

Conditions studied

  • Chronic Myeloid Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 21 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with chronic myeloid leukemia;
  • Age: 18-65 years,gender:both.
  • Weight: standard weight ± 20% within, and avoid weight disparity is too large;
  • No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib;
  • Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months;
  • No other malignancy;
  • Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal);
  • Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases;
  • Pregnant or lactating women and be sensitive to drug;
  • Subjects are thought unsuitable for the study by investigators;
  • Inability to comply with protocol or study procedures in the opinion of the investigator;
  • Attending other clinical trials or attended other clinical trials 3 months ago.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    mesylate imatinib capsule

    Single and multiple oral mesylate imatinib capsule 400mg qd

    Drug: mesylate imatinib capsule

  • Active comparator
    Glivec

    Single and multiple oral Glivec 400mg qd

    Drug: Glivec

Interventions

  • Drugmesylate imatinib capsule

    Single and multiple oral mesylate imatinib capsule 400mg qd

    Also known as: 111201

  • DrugGlivec

    Single and multiple oral Glivec 400mg qd

    Also known as: Mesylate Imatinib tablet

06

What researchers measure

Primary outcomes

  1. Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose

    Time frame: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose

07

Results

Posted May 19, 2015

Participant flow

First Intervention (13 Days)
Participant flow — First Intervention (13 Days)
MilestoneMesylate Imatinib Capsule First, Then GlivecGlivec First, Then Mesylate Imatinib Capsule
Started1011
Completed1011
Not completed00
Washout (10 Days)
Participant flow — Washout (10 Days)
MilestoneMesylate Imatinib Capsule First, Then GlivecGlivec First, Then Mesylate Imatinib Capsule
Started1011
Completed1011
Not completed00
Second Intervention (13 Days)
Participant flow — Second Intervention (13 Days)
MilestoneMesylate Imatinib Capsule First, Then GlivecGlivec First, Then Mesylate Imatinib Capsule
Started1011
Completed1011
Not completed00

Outcome measures

PrimaryArea Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
Time frame:
predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
Reported as:
Mean · mcg*hr/mL
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
mcg*hr/mLMesylate Imatinib CapsuleGlivec
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose37256 ± 1144237206 ± 10620
Statistical analysis
  • Mesylate Imatinib Capsule vs Glivec · ANOVA · p = <0.05

Adverse events

Collected over 29 days. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mesylate Imatinib Capsule—0/21 (0%)10/21 (47.6%)
Glivec—0/21 (0%)13/21 (61.9%)
Most frequent other events
Most frequent other events
EventMesylate Imatinib CapsuleGlivec
nausea and vomitGastrointestinal disorders10/2113/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Mesylate Imatinib Capsule First, Then GlivecGlivec First, Then Mesylate Imatinib CapsuleTotal
<=18 years112
Between 18 and 65 years91019
>=65 years000
Age, Continuous
Age, Continuous(years)Mesylate Imatinib Capsule First, Then GlivecGlivec First, Then Mesylate Imatinib CapsuleTotal
Geometric mean33 (17 to 59)33 (17 to 59)33 (17 to 59)
Sex: Female, Male
Sex: Female, Male(Participants)Mesylate Imatinib Capsule First, Then GlivecGlivec First, Then Mesylate Imatinib CapsuleTotal
Female358
Male7613
Region of Enrollment
Region of Enrollment(participants)Mesylate Imatinib Capsule First, Then GlivecGlivec First, Then Mesylate Imatinib CapsuleTotal
China101121
08

Study locations

1 site
  • Shanghai Jiaotong University School of Medicine Ruijin Hospital
    Shanghai, 200025, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01795716
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Feb 21, 2013
Start date
Sep 2012
Primary completion
Jun 2013
Completion
Jun 2013
Results posted
May 19, 2015
Last update
May 19, 2015

Study contacts

Shen Zh xiang, doctor
principal investigator · Shanghai Jiaotong University School of Medicine Ruijin Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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