Chronic Myeloid LeukemiaPhase 1NCT01795716
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
A Phase 1 study testing mesylate imatinib capsule and Glivec in people with Chronic Myeloid Leukemia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- mesylate imatinib capsule and Glivec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Jun 2013
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, 200025
About this study
- 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).
- Experimental Design： Two-period crossover design
- Test drug: imatinib mesylate capsule Reference drug: Glivec
- 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.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- mesylate imatinib capsule, Glivec
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesylate imatinib capsuleDrug
Also called 111201
Single and multiple oral mesylate imatinib capsule 400mg qd
GlivecDrug
Also called Mesylate Imatinib tablet
Single and multiple oral Glivec 400mg qd
| Study group | Role | What they receive |
|---|---|---|
| mesylate imatinib capsule | Experimental | Single and multiple oral mesylate imatinib capsule 400mg qd Receives: Drug: mesylate imatinib capsule |
| Glivec | Active comparator | Single and multiple oral Glivec 400mg qd Receives: Drug: Glivec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose
Measured: predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shen Zh xiang, doctor, Principal investigator, Shanghai Jiaotong University School of Medicine Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795716
- Sponsor's protocol ID
- YMTN-1.0
- Status last verified
- May 2015
- First submitted
- 6 Feb 2013
- Last updated
- 19 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes