Healthy VolunteersPhase 1NCT02185066
Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR
A Phase 1 study testing Atorvastatin 20mg and Metformin XR 500mg (Reference) and CJ-30056 20/500mg (Test) in people with Healthy Volunteers, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Atorvastatin 20mg and Metformin XR 500mg (Reference) and CJ-30056 20/500mg (Test)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Nov 2014
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to adhere to protocol requirements and sign a informed consent form
- Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
Who cannot join
- Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
- Symptom of an acute illness within 4 weeks prior to drug administration
- History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
- History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
- History of clinically significant allergies including drug allergies
- History of clinically significant allergies about atorvastatin or metformin
Show all 18Show fewer
- Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
- History of myopathy
- Clinical laboratory test values are outside the accepted normal range
- AST or ALT >1.25 times to normal range
- Total bilirubin >1.5 times to normal range
- e-GFR <90 mL/min
- History of drug, caffein(caffein > 5 cups/day), smoking (cigarette > 10/day) or alcohol abuse(alcohol > 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
- Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
- Donated blood within 60 days prior to dosing
- Participated in a previous clinical trial within 60 days prior to dosing
- Use of any other medication, including herbal products, within 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
This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Atorvastatin 20mg and Metformin XR 500mg (Reference), CJ-30056 20/500mg (Test)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mg and Metformin XR 500mg (Reference)Drug
Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.
CJ-30056 20/500mg (Test)Drug
Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Single-dose crossover
1. Reference: Atorvastatin 20mg and Metformin XR 500mg
2. Test: CJ-30056 20/500mg
Once daily Oral administration with 7days of washout period Receives: Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference); Drug: CJ-30056 20/500mg (Test) |
| Group 2 | Experimental | Single-dose crossover
1. Test: CJ-30056 20/500mg
2. Reference: Atorvastatin 20mg and Metformin XR 500mg
Once daily Oral administration with 7days of washout period Receives: Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference); Drug: CJ-30056 20/500mg (Test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of Atorvastatin
Measured: Upto 36 hours
Maximum plasma concentration (Cmax) of Metformin
Measured: Upto 24 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin
Measured: Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Metformin
Measured: Upto 24 hours
Secondary outcomes (4)
Maximum plasma concentration (Cmax) of 2-OH-atorvastatin
Measured: Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin
Measured: Upto 36 hours
CL/F of Atorvastatin and Metformin
Measured: Upto 36 hours
Vd/F of Atorvastatin and Metformin
Measured: Upto 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong-lyul Ghim, MD. PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185066
- Sponsor's protocol ID
- CJ_ATM_103
- Status last verified
- Dec 2016
- First submitted
- 7 Jul 2014
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR
- ClinicalTrials.gov ID
- NCT02185066
- Acronym / sponsor ID
- CJ_ATM_103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Jul 2014 (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 safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference), Drug: CJ-30056 20/500mg (Test)Single-dose crossover 1. Reference: Atorvastatin 20mg and Metformin XR 500mg 2. Test: CJ-30056 20/500mg Once daily Oral administration with 7days of washout period |
| Group 2 | Experimental | Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference), Drug: CJ-30056 20/500mg (Test)Single-dose crossover 1. Test: CJ-30056 20/500mg 2. Reference: Atorvastatin 20mg and Metformin XR 500mg Once daily Oral administration with 7days of washout period |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing to adhere to protocol requirements and sign a informed consent form
- Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight
- Subjects with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
Key exclusion criteria (18 listed)
- Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
- Symptom of an acute illness within 4 weeks prior to drug administration
- History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
- History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
- History of clinically significant allergies including drug allergies
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 |
|---|---|---|
| Atorvastatin 20mg and Metformin XR 500mg (Reference)Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between. | Drug | Group 1, Group 2 |
| CJ-30056 20/500mg (Test)Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between. Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between. | Drug | Group 1, Group 2 |
Primary outcome
Maximum plasma concentration (Cmax) of Atorvastatin
Time frame: Upto 36 hours
Maximum plasma concentration (Cmax) of Metformin
Time frame: Upto 24 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin
Time frame: Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of Metformin
Time frame: Upto 24 hours
4 secondary outcomes
Maximum plasma concentration (Cmax) of 2-OH-atorvastatin
Time frame: Upto 36 hours
Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin
Time frame: Upto 36 hours
CL/F of Atorvastatin and Metformin
Time frame: Upto 36 hours
Vd/F of Atorvastatin and Metformin
Time frame: Upto 36 hours
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 29 Dec 2016.
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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.
Jong-lyul Ghim, MD. PhD principal investigator
Inje University
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 Atorvastatin 20mg and Metformin XR 500mg (Reference) and CJ-30056 20/500mg (Test) in people with Healthy Volunteers, 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 4 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 29 Dec 2016. 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 plasma concentration (Cmax) of Atorvastatin (time frame: Upto 36 hours). The study lists 4 primary outcomes in all. 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 29 Dec 2016.