HealthyPhase 1NCT01926548
to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
A Phase 1 study testing CJ Imatinib mesylate tablet and Gleevec film-coated tablet 2 x 100mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CJ Imatinib mesylate tablet and Gleevec film-coated tablet 2 x 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers in the age between 20 and 55 years old
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
- Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
- Available for the entire study period
- Willing to adhere to protocol requirements and sign a informed consent form
Who cannot join
- History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- Clinically significant vital sign
- SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg
- DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg
- History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- History of clinically significant allergies, including imatinib
Show all 18Show fewer
- Clinical laboratory test values are outside the accepted normal range
- AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range
- Estimated GFR(Glomerular Filtration Rate) < 80 mL/min
- History of caffeine, alcohol, smoking abuse
- caffeine > 4 cups/day
- grapefruit juice > 4 cups/day
- smoking > 20 cigarettes/day
- alcohol > 140g/week
- Participated in a previous clinical trial within 3 months prior to dosing
- Donated blood within 60 days prior to dosing
- Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing
- Subjects considered as unsuitable based on medical judgement by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- CJ Imatinib mesylate tablet, Gleevec film-coated tablet 2 x 100mg
- Keywords
- Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ Imatinib mesylate tabletDrug
Gleevec film-coated tablet 2 x 100mgDrug
| Study group | Role | What they receive |
|---|---|---|
| CJ Imatinib 200mg | Experimental | 1 tablet(200mg) a day,PO,QD Receives: Drug: CJ Imatinib mesylate tablet |
| Gleevec 100mg | Active comparator | 2 tablet(100mg) a day,PO,QD Receives: Drug: Gleevec film-coated tablet 2 x 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentration, Area under the concentration-time curve from zero to infinity
Administration of IP : 1day
Measured: Blood sampling up to 72hs post dose(16 times).
Secondary outcomes (1)
Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity
Administration of IP : 1 day
Measured: Blood sampling up to 72hs post dose(16 times).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926548
- Sponsor's protocol ID
- CJ_IMM_101
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01926548
- Acronym / sponsor ID
- CJ_IMM_101
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ Imatinib 200mg | Experimental | Drug: CJ Imatinib mesylate tablet1 tablet(200mg) a day,PO,QD |
| Gleevec 100mg | Active comparator | Drug: Gleevec film-coated tablet 2 x 100mg2 tablet(100mg) a day,PO,QD |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male volunteers in the age between 20 and 55 years old
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
- Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
- Available for the entire study period
- Willing to adhere to protocol requirements and sign a informed consent form
Key exclusion criteria (18 listed)
- History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- Clinically significant vital sign
- History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- History of clinically significant allergies, including imatinib
- Clinical laboratory test values are outside the accepted normal range
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 |
|---|---|---|
| CJ Imatinib mesylate tablet | Drug | CJ Imatinib 200mg |
| Gleevec film-coated tablet 2 x 100mg | Drug | Gleevec 100mg |
Primary outcome
maximum concentration, Area under the concentration-time curve from zero to infinity
Time frame: Blood sampling up to 72hs post dose(16 times).
Administration of IP : 1day
1 secondary outcome
Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity
Time frame: Blood sampling up to 72hs post dose(16 times).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CJ Imatinib mesylate tablet and Gleevec film-coated tablet 2 x 100mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
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 5 inclusion and 18 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 21 Aug 2013. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximum concentration, Area under the concentration-time curve from zero to infinity (time frame: Blood sampling up to 72hs post dose(16 times).). 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 21 Aug 2013.