HealthyPhase 1NCT01765023
Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
A Phase 1 study testing Period I : atorvastatin, Period II : atorvastatin and metformin and Period I : metformin, Period II : atorvastatin and metformin in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy 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?
- Period I : atorvastatin, Period II : atorvastatin and metformin and Period I : metformin, Period II : atorvastatin and metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Jan 2013
- 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
- Willing to adhere to protocol requirements and sign a informed consent form
- Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- 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 for this trial by investigators
Who cannot join
- Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- Subjects with Symptoms of acute disease within 28days prior to study medication dosing
- Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
- Subjects with a history of abdominal surgery within food and water limit
- Subjects with a history of clinically significant allergies including drug allergies
- Subjects with anaphylaxis to atorvastatin and/or metformin
Show all 19Show fewer
- Subjects with a history or plan iodine radiotherapy within 28 days prior to drug administration
- Subjects with a history of myopathy
- Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- 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
- Creatinine clearance <90 mL/min
- Subjects with a history of drug, caffeine and alcohol abuse(caffeine > 5cups/day, cigarette > 10/day, alcohol > 30g/day) or have ever drank 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
- Subjects who have received any drugs that might confound the results of the trial based on medical judgement by investigators within 10days prior to drug administration
- Subjects considered as unsuitable based on medical judgement by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers
- Conditions
- Healthy
- Being tested
- Period I : atorvastatin, Period II : atorvastatin and metformin, Period I : metformin, Period II : atorvastatin and metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period I : atorvastatin, Period II : atorvastatin and metforminDrug
Period I : metformin, Period II : atorvastatin and metforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | single administration : atorvastatin 40mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) Receives: Drug: Period I : atorvastatin, Period II : atorvastatin and metformin |
| Part B | Experimental | single administration : metformin XR 1000mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) Receives: Drug: Period I : metformin, Period II : atorvastatin and metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate PK interaction of atorvastatin and metformin
Measured: Throughout the study
Secondary outcomes (1)
To Evaluate PK interaction of 2-OH-atorvastatin and metformin
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionJan 2013
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT01765023
- Sponsor's protocol ID
- CJ_ATM_101
- Status last verified
- Apr 2013
- First submitted
- 12 Dec 2012
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence Study to Evaluate Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01765023
- Acronym / sponsor ID
- CJ_ATM_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Jan 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.
The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin and metformin single or co-administered in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Period I : atorvastatin, Period II : atorvastatin and metforminsingle administration : atorvastatin 40mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) |
| Part B | Experimental | Drug: Period I : metformin, Period II : atorvastatin and metforminsingle administration : metformin XR 1000mg, qd, 7days(oral) combination administration : atorvastatin 40mg and metformin XR 1000mg, qd, 7days(oral) |
Who may qualify
- Ages
- 20 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
- Healthy male volunteers who are in age range of 20-55 years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
- 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 for this trial by investigators
Key exclusion criteria (19 listed)
- Subjects taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- Subjects with Symptoms of acute disease within 28days prior to study medication dosing
- Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
- Subjects with a history of abdominal surgery within food and water limit
- Subjects with a 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 |
|---|---|---|
| Period I : atorvastatin, Period II : atorvastatin and metformin | Drug | Part A |
| Period I : metformin, Period II : atorvastatin and metformin | Drug | Part B |
Primary outcome
To Evaluate PK interaction of atorvastatin and metformin
Time frame: Throughout the study
1 secondary outcome
To Evaluate PK interaction of 2-OH-atorvastatin and metformin
Time frame: Throughout the study
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 9 Apr 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 Period I : atorvastatin, Period II : atorvastatin and metformin and Period I : metformin, Period II : atorvastatin and metformin 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 4 inclusion and 19 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 9 Apr 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?
To Evaluate PK interaction of atorvastatin and metformin (time frame: Throughout the study). 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 9 Apr 2013.