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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
- ClinicalTrials.gov ID
- NCT01795716
- Acronym / sponsor ID
- YMTN-1.0
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Posted 19 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesylate imatinib capsule | Experimental | Drug: mesylate imatinib capsuleSingle and multiple oral mesylate imatinib capsule 400mg qd |
| Glivec | Active comparator | Drug: GlivecSingle and multiple oral Glivec 400mg qd |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesylate imatinib capsuleAlso: 111201Single and multiple oral mesylate imatinib capsule 400mg qd | Drug | mesylate imatinib capsule |
| GlivecAlso: Mesylate Imatinib tabletSingle and multiple oral Glivec 400mg qd | Drug | Glivec |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Zh xiang, doctor principal investigator
Shanghai Jiaotong University School of Medicine Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.